Mastering Pharmacovigilance: Effective Drug Safety and Risk Management Strategies
You're under pressure. Regulatory scrutiny is intensifying. Safety data is piling up faster than your team can process it. A single oversight could delay approvals, trigger compliance penalties, or worse-jeopardize patient lives. The industry isn’t waiting. Top pharmaceutical and biotech firms now expect safety professionals who don’t just report adverse events, but anticipate risks, design robust safety systems, and lead with confidence in cross-functional teams. If you're stuck using outdated templates or basic signal detection checklists, you're falling behind. Mastering Pharmacovigilance: Effective Drug Safety and Risk Management Strategies isn’t another theory-heavy review. It’s a precision-engineered system that transforms how you manage drug safety from preclinical through post-marketing stages. This course equips you to build proactive safety frameworks, streamline global compliance, and deliver real value-fast. One recent participant, Fatima K., Drug Safety Associate at a leading EU-based CRO, told us: “After just two modules, I redesigned our case processing workflow. The next audit came back with zero findings for the first time in three years. I was promoted six weeks later.” She didn’t just learn rules-she learned to lead with precision. From fragmented data handling to board-level risk communication, this course bridges the gap between reactive compliance and strategic safety leadership. You’ll gain the clarity, tools, and structured methodologies to produce measurable impact-within 30 days. Here’s how this course is structured to help you get there.Course Format & Delivery Details Self-Paced, On-Demand Learning Designed for Real-World Professionals
This course is self-paced, with immediate online access upon enrollment. There are no fixed schedules, mandatory live sessions, or time-bound modules. You progress entirely on your terms-whether that’s 20 minutes during a lunch break or deep dives over weekends. Most learners complete the program in 4–6 weeks while working full time. Many apply core frameworks to active projects within the first 10 days, reporting faster case evaluations, more insightful aggregate reporting, and stronger alignment with regulatory expectations. Lifetime Access & Continuous Updates
You receive lifetime access to all course materials, including every future update at no additional cost. As pharmacovigilance guidelines evolve-from EMA reflections to FDA safety reporting changes-you’ll automatically have access to revised content, ensuring your knowledge remains compliant and cutting-edge. Your access is globally available, 24/7, and fully mobile-friendly. Review critical workflows on your phone during a commute, or pull up a risk management plan template on your tablet during a meeting. The system adapts to your workflow-not the other way around. Direct Instructor Support & Expert Guidance
You are not learning in isolation. Throughout the course, you’ll have access to structured instructor support. All guidance is delivered through responsive, role-specific frameworks, real-time feedback mechanisms, and curated reference models-ensuring you apply concepts correctly and confidently. Our lead advisors are active pharmacovigilance leaders with 15+ years of experience across global pharma, CROs, and regulatory agencies. Their insights are embedded directly into the materials you use, giving you the operational clarity most professionals only gain after years of trial and error. Certificate of Completion Issued by The Art of Service
Upon finishing the course, you’ll earn a formal Certificate of Completion issued by The Art of Service, a globally recognized name in professional certification frameworks. This credential is trusted by employers in over 80 countries and reflects a mastery of practical, audit-ready pharmacovigilance skills-not just academic compliance. Add it to your LinkedIn, resume, or performance review. It signals that you operate at the highest standard of drug safety practice, with structured expertise that drives ROI and reduces organizational risk. No Hidden Fees. Full Transparency.
Our pricing is straightforward. There are no hidden fees, tiered upsells, or subscription traps. What you see is exactly what you get-a comprehensive, one-time investment in career-defining knowledge. We accept all major payment methods including Visa, Mastercard, and PayPal. Transactions are fully encrypted and processed through a PCI-compliant gateway for your security. Zero-Risk Enrollment: 30-Day Satisfied or Refunded Guarantee
We stand behind the value of this course with a no-questions-asked, 30-day refund policy. If you complete the first three modules and don’t feel a significant gain in clarity, confidence, or practical skill, simply request a full refund. This isn’t just a guarantee-it’s our commitment to ensuring you achieve real results. After Enrollment: Confirmation and Access
Following enrollment, you’ll receive a confirmation email. Your access details and course entry instructions will be sent separately once your materials are prepared and verified-ensuring maximum accuracy and security. Will This Work for Me?
Yes. This course is designed for professionals at all levels-from pharmacovigilance officers in emerging markets to safety scientists in multinational firms. It works even if:
- You’re transitioning from a related role like clinical operations or regulatory affairs.
- Your organization lacks mature PV systems.
- You’ve never led a PSUR or prepared for an EMA audit.
- English is not your first language.
- You work part-time or in a high-pressure, understaffed environment. Why? Because we don’t teach abstract theory. We deliver battle-tested workflows, standardized templates, and decision trees used by top-tier companies-all modified for real-world constraints. With step-by-step implementation guides, role-specific checklists, and audit-ready frameworks, you’ll build competence systematically, regardless of your starting point.
Extensive and Detailed Course Curriculum
Module 1: Foundations of Modern Pharmacovigilance - Historical evolution of drug safety and key regulatory milestones
- Understanding pharmacovigilance in the context of global public health
- Differentiating between safety, efficacy, and risk-benefit assessment
- Core definitions: adverse event, adverse drug reaction, causality, seriousness
- The role of spontaneous reporting systems across regions
- Introduction to signal detection and risk management life cycles
- WHO UMC and CIOMS: key organizations shaping global standards
- Legal and ethical foundations of patient safety monitoring
- Global regulatory convergence trends and ICH initiatives
- Basic structure of a pharmacovigilance system master file (PSMF)
Module 2: Global Regulatory Frameworks and Compliance Structures - Comparative analysis of EMA, FDA, PMDA, Health Canada, and TGA requirements
- Understanding EudraVigilance and FAERS architecture
- Mandatory reporting timelines for serious and non-serious ADRs
- Legal obligations for MAHs and third-party reporting entities
- Role of national competent authorities in signal validation
- EU pharmacovigilance legislation: Directive 2010/84/EU and Regulation (EU) No 1235/2010
- 21 CFR Part 310 and 314 requirements for US submissions
- CHMP Guideline on Good Pharmacovigilance Practices (GVP) overview
- Pharmacovigilance requirements in emerging markets (Latin America, Middle East, Southeast Asia)
- Handling regulatory expectations during post-authorization safety studies
Module 3: Case Processing and Individual Case Safety Reports (ICSRs) - Step-by-step workflow for initial case intake and triage
- Identifying reportability criteria: event seriousness, expectedness, and product relationship
- Source document evaluation: clinical notes, discharge summaries, and lab reports
- Data fields in ICH E2B(R3) and MedDRA coding essentials
- WHO Drug Dictionary (WHO-DD) coding principles
- Handling unstructured narratives and incomplete submissions
- Age, weight, and concomitant medication validation techniques
- Assessing patient follow-up requirements and data gap resolution
- Processing literature cases and handling conference abstracts
- Automation and data extraction tools for case processing efficiency
Module 4: Causality Assessment and Signal Detection Methodologies - Applying the Naranjo Algorithm for preliminary causality
- WHO-UMC causality grading: certain, probable, possible, unlikely
- Bradford Hill criteria for pharmacological causality evaluation
- Introduction to disproportionality analysis (PRR, ROR, IC)
- Signal detection using spontaneous reporting databases
- Setting thresholds for statistical signal generation
- Role of expert review panels in signal validation
- Integrating clinical context into statistical findings
- Signal assessment during outbreaks and public health emergencies
- Differentiating true signals from reporting bias and noise
Module 5: Risk Management Planning and Risk Minimization Strategies - Structure and content of the Risk Management Plan (RMP)
- Developing safety specifications, including SOIs and SOSs
- Designing pharmacovigilance planning (PVP) and post-authorization measures
- Creating REMS programs for FDA-regulated products
- Developing ESP, PASS, and PMCF as risk minimization tools
- Effectiveness checks for risk minimization materials
- User testing for patient medication guides and healthcare professional letters
- Designing safe dispensing and restricted distribution programs
- Incorporating patient registries into risk mitigation
- Balancing risk communication with market access needs
Module 6: Aggregate Reporting and Periodic Safety Updates - Structure and purpose of the PSUR and PBRER
- ICH E2C(R2) requirements for periodic reporting
- Data lock point selection and interval calculation methods
- Summary of Product Characteristics (SmPC) reconciliation process
- Benefit-risk evaluation frameworks in aggregate reporting
- Updating safety concerns and emerging risks in narratives
- Presenting tables and listings: AEs, laboratory abnormalities, mortality
- Handling orphan drugs and products with limited exposure
- Regional variations in PSUR submission formats (e.g. EU PSUR vs. US DSUR)
- Streamlining aggregate report production with standardized templates
Module 7: Pharmacovigilance in Clinical Development - Safety responsibilities during Phase I to Phase IV trials
- Designing safety monitoring plans for investigator-initiated studies
- Role of the Safety Monitoring Committee (SMC) and DSMBs
- Expedited reporting requirements for SUSARs
- ICH E2A guidelines for clinical safety data management
- Blinded review procedures and unblinding protocols
- Data Safety Monitoring Board (DSMB) reporting structures
- Integrating safety data across multiple trials
- Preparing clinical study reports (CSRs) with robust safety sections
- Handling protocol deviations related to safety events
Module 8: Literature Monitoring and Data Mining - Developing a systematic literature search strategy
- Using PubMed, Embase, and Google Scholar for safety data capture
- Automated alerts and keyword filtering for ongoing monitoring
- Validation of case reports found in scientific publications
- Handling case series and pooled analyses for signal detection
- Data mining open-source and preprint databases
- Assessing study quality and publication bias in safety findings
- Integrating literature findings into aggregate reports
- Managing duplicate reporting from clinical trials and literature
- Using AI-powered tools to enhance literature screening accuracy
Module 9: Global Safety Database Management - Key components of an effective safety database architecture
- Oracle Argus, ARISg, and Veeva Vault PV configuration best practices
- Data migration strategies from legacy systems
- Validation and audit-readiness of database queries
- Ensuring data integrity and ALCOA+ compliance
- Standardizing dictionary coding across multiple products
- Role of business continuity and disaster recovery in PV systems
- Interface management between safety databases and EDC systems
- Implementing role-based access controls (RBAC) for data security
- Database optimization for fast signal detection and reporting
Module 10: Inspections, Audits, and Quality Assurance - Preparing for EMA GVP inspections and FDA PQS audits
- Conducting internal PV system audits using risk-based approaches
- Documenting audit trails and data retention policies
- Responding to regulatory inspection findings and observations
- Designing corrective and preventive action (CAPA) plans
- Third-party vendor audits: CROs, call centers, and data processors
- Quality oversight in outsourced pharmacovigilance services
- Implementing continuous quality improvement (CQI) in PV
- Audit checklist development for PSMF and SOP compliance
- Training audit teams and preparing inspection response protocols
Module 11: Benefit-Risk Assessment and Decision Frameworks - Quantitative and qualitative methods in benefit-risk evaluation
- Using BRAT, EvaCAT, and other structured tools
- Incorporating patient perspectives into risk assessments
- Presenting benefit-risk to regulatory authorities and internal stakeholders
- Managing risk during public health emergencies (e.g. pandemic vaccines)
- Updating risk management based on new clinical evidence
- Handling therapeutic areas with high unmet medical need
- Communicating uncertainty in post-marketing safety profiles
- Decision trees for market suspension, label changes, or risk communication
- Aligning benefit-risk with health technology assessment (HTA) bodies
Module 12: Pharmacovigilance in Special Populations - Safety monitoring in pediatric populations
- Geriatric pharmacovigilance: polypharmacy and reporting challenges
- Drug safety in pregnancy and lactation (ICH E2B guidelines)
- Monitoring ADRs in oncology and immuno-oncology agents
- Cardiovascular safety signals and QT prolongation risks
- Hepatotoxicity and liver injury signal patterns
- Managing immune-mediated adverse reactions (irAEs)
- Psychiatric ADRs: suicidality, agitation, and cognitive effects
- Safety of biosimilars and complex generics
- Rare disease therapies: challenges in safety data collection
Module 13: Real-World Evidence and Post-Marketing Surveillance - Using electronic health records (EHR) for safety signal detection
- Leveraging claims databases and insurance data sources
- Designing post-authorization safety studies (PASS)
- Active surveillance using distributed data networks
- Propensity scoring and confounding adjustment in database studies
- Signal validation through targeted chart reviews
- Integrating social media and patient forums into surveillance (with caveats)
- Defining study endpoints for safety rather than efficacy
- Reporting real-world evidence findings to regulators
- Best practices for communicating RWE-based safety updates to HCPs
Module 14: Organizational Structures and PV System Oversight - Defining the role of the Qualified Person for Pharmacovigilance (QPPV)
- Establishing a pharmacovigilance department in a small biotech
- Centralized vs. decentralized PV operations in global firms
- Outsourcing PV to CROs: contracts, KPIs, and oversight
- Developing a pharmacovigilance system master file (PSMF)
- Annual review and update process for the PSMF
- Defining PV responsibilities across departments
- Implementing PV governance committees and SOPs
- Ensuring compliance across mergers, acquisitions, and product licensing
- Managing transitions during vendor or system changes
Module 15: Communication and Stakeholder Engagement - Drafting effective Dear Healthcare Professional (DHCP) letters
- Preparing patient information leaflets and safety communications
- Engaging with patient advocacy groups on safety issues
- Presenting safety findings to internal governance boards
- Media relations during safety crises
- Communicating label changes and risk mitigation to sales teams
- Internal escalation pathways for critical safety events
- Global alignment of messaging across regions
- Handling inquiries from journalists and public bodies
- Psychological safety in team reporting and near-miss learning
Module 16: Career Advancement and Certification Readiness - Mapping course knowledge to recognized certification exams (e.g. RAC, DPA)
- Building a professional PV portfolio with templates and samples
- Highlighting PV expertise in performance reviews and job applications
- Negotiating salary increases using certification and project impact
- Transitioning into leadership roles: Safety Lead, PV Head, Global QPPV
- Networking strategies within global PV communities
- Contributing to industry guidelines and working groups
- Presenting at scientific meetings and publishing safety insights
- Continuous learning pathways beyond this course
- Final review and certification exam preparation guide
Module 1: Foundations of Modern Pharmacovigilance - Historical evolution of drug safety and key regulatory milestones
- Understanding pharmacovigilance in the context of global public health
- Differentiating between safety, efficacy, and risk-benefit assessment
- Core definitions: adverse event, adverse drug reaction, causality, seriousness
- The role of spontaneous reporting systems across regions
- Introduction to signal detection and risk management life cycles
- WHO UMC and CIOMS: key organizations shaping global standards
- Legal and ethical foundations of patient safety monitoring
- Global regulatory convergence trends and ICH initiatives
- Basic structure of a pharmacovigilance system master file (PSMF)
Module 2: Global Regulatory Frameworks and Compliance Structures - Comparative analysis of EMA, FDA, PMDA, Health Canada, and TGA requirements
- Understanding EudraVigilance and FAERS architecture
- Mandatory reporting timelines for serious and non-serious ADRs
- Legal obligations for MAHs and third-party reporting entities
- Role of national competent authorities in signal validation
- EU pharmacovigilance legislation: Directive 2010/84/EU and Regulation (EU) No 1235/2010
- 21 CFR Part 310 and 314 requirements for US submissions
- CHMP Guideline on Good Pharmacovigilance Practices (GVP) overview
- Pharmacovigilance requirements in emerging markets (Latin America, Middle East, Southeast Asia)
- Handling regulatory expectations during post-authorization safety studies
Module 3: Case Processing and Individual Case Safety Reports (ICSRs) - Step-by-step workflow for initial case intake and triage
- Identifying reportability criteria: event seriousness, expectedness, and product relationship
- Source document evaluation: clinical notes, discharge summaries, and lab reports
- Data fields in ICH E2B(R3) and MedDRA coding essentials
- WHO Drug Dictionary (WHO-DD) coding principles
- Handling unstructured narratives and incomplete submissions
- Age, weight, and concomitant medication validation techniques
- Assessing patient follow-up requirements and data gap resolution
- Processing literature cases and handling conference abstracts
- Automation and data extraction tools for case processing efficiency
Module 4: Causality Assessment and Signal Detection Methodologies - Applying the Naranjo Algorithm for preliminary causality
- WHO-UMC causality grading: certain, probable, possible, unlikely
- Bradford Hill criteria for pharmacological causality evaluation
- Introduction to disproportionality analysis (PRR, ROR, IC)
- Signal detection using spontaneous reporting databases
- Setting thresholds for statistical signal generation
- Role of expert review panels in signal validation
- Integrating clinical context into statistical findings
- Signal assessment during outbreaks and public health emergencies
- Differentiating true signals from reporting bias and noise
Module 5: Risk Management Planning and Risk Minimization Strategies - Structure and content of the Risk Management Plan (RMP)
- Developing safety specifications, including SOIs and SOSs
- Designing pharmacovigilance planning (PVP) and post-authorization measures
- Creating REMS programs for FDA-regulated products
- Developing ESP, PASS, and PMCF as risk minimization tools
- Effectiveness checks for risk minimization materials
- User testing for patient medication guides and healthcare professional letters
- Designing safe dispensing and restricted distribution programs
- Incorporating patient registries into risk mitigation
- Balancing risk communication with market access needs
Module 6: Aggregate Reporting and Periodic Safety Updates - Structure and purpose of the PSUR and PBRER
- ICH E2C(R2) requirements for periodic reporting
- Data lock point selection and interval calculation methods
- Summary of Product Characteristics (SmPC) reconciliation process
- Benefit-risk evaluation frameworks in aggregate reporting
- Updating safety concerns and emerging risks in narratives
- Presenting tables and listings: AEs, laboratory abnormalities, mortality
- Handling orphan drugs and products with limited exposure
- Regional variations in PSUR submission formats (e.g. EU PSUR vs. US DSUR)
- Streamlining aggregate report production with standardized templates
Module 7: Pharmacovigilance in Clinical Development - Safety responsibilities during Phase I to Phase IV trials
- Designing safety monitoring plans for investigator-initiated studies
- Role of the Safety Monitoring Committee (SMC) and DSMBs
- Expedited reporting requirements for SUSARs
- ICH E2A guidelines for clinical safety data management
- Blinded review procedures and unblinding protocols
- Data Safety Monitoring Board (DSMB) reporting structures
- Integrating safety data across multiple trials
- Preparing clinical study reports (CSRs) with robust safety sections
- Handling protocol deviations related to safety events
Module 8: Literature Monitoring and Data Mining - Developing a systematic literature search strategy
- Using PubMed, Embase, and Google Scholar for safety data capture
- Automated alerts and keyword filtering for ongoing monitoring
- Validation of case reports found in scientific publications
- Handling case series and pooled analyses for signal detection
- Data mining open-source and preprint databases
- Assessing study quality and publication bias in safety findings
- Integrating literature findings into aggregate reports
- Managing duplicate reporting from clinical trials and literature
- Using AI-powered tools to enhance literature screening accuracy
Module 9: Global Safety Database Management - Key components of an effective safety database architecture
- Oracle Argus, ARISg, and Veeva Vault PV configuration best practices
- Data migration strategies from legacy systems
- Validation and audit-readiness of database queries
- Ensuring data integrity and ALCOA+ compliance
- Standardizing dictionary coding across multiple products
- Role of business continuity and disaster recovery in PV systems
- Interface management between safety databases and EDC systems
- Implementing role-based access controls (RBAC) for data security
- Database optimization for fast signal detection and reporting
Module 10: Inspections, Audits, and Quality Assurance - Preparing for EMA GVP inspections and FDA PQS audits
- Conducting internal PV system audits using risk-based approaches
- Documenting audit trails and data retention policies
- Responding to regulatory inspection findings and observations
- Designing corrective and preventive action (CAPA) plans
- Third-party vendor audits: CROs, call centers, and data processors
- Quality oversight in outsourced pharmacovigilance services
- Implementing continuous quality improvement (CQI) in PV
- Audit checklist development for PSMF and SOP compliance
- Training audit teams and preparing inspection response protocols
Module 11: Benefit-Risk Assessment and Decision Frameworks - Quantitative and qualitative methods in benefit-risk evaluation
- Using BRAT, EvaCAT, and other structured tools
- Incorporating patient perspectives into risk assessments
- Presenting benefit-risk to regulatory authorities and internal stakeholders
- Managing risk during public health emergencies (e.g. pandemic vaccines)
- Updating risk management based on new clinical evidence
- Handling therapeutic areas with high unmet medical need
- Communicating uncertainty in post-marketing safety profiles
- Decision trees for market suspension, label changes, or risk communication
- Aligning benefit-risk with health technology assessment (HTA) bodies
Module 12: Pharmacovigilance in Special Populations - Safety monitoring in pediatric populations
- Geriatric pharmacovigilance: polypharmacy and reporting challenges
- Drug safety in pregnancy and lactation (ICH E2B guidelines)
- Monitoring ADRs in oncology and immuno-oncology agents
- Cardiovascular safety signals and QT prolongation risks
- Hepatotoxicity and liver injury signal patterns
- Managing immune-mediated adverse reactions (irAEs)
- Psychiatric ADRs: suicidality, agitation, and cognitive effects
- Safety of biosimilars and complex generics
- Rare disease therapies: challenges in safety data collection
Module 13: Real-World Evidence and Post-Marketing Surveillance - Using electronic health records (EHR) for safety signal detection
- Leveraging claims databases and insurance data sources
- Designing post-authorization safety studies (PASS)
- Active surveillance using distributed data networks
- Propensity scoring and confounding adjustment in database studies
- Signal validation through targeted chart reviews
- Integrating social media and patient forums into surveillance (with caveats)
- Defining study endpoints for safety rather than efficacy
- Reporting real-world evidence findings to regulators
- Best practices for communicating RWE-based safety updates to HCPs
Module 14: Organizational Structures and PV System Oversight - Defining the role of the Qualified Person for Pharmacovigilance (QPPV)
- Establishing a pharmacovigilance department in a small biotech
- Centralized vs. decentralized PV operations in global firms
- Outsourcing PV to CROs: contracts, KPIs, and oversight
- Developing a pharmacovigilance system master file (PSMF)
- Annual review and update process for the PSMF
- Defining PV responsibilities across departments
- Implementing PV governance committees and SOPs
- Ensuring compliance across mergers, acquisitions, and product licensing
- Managing transitions during vendor or system changes
Module 15: Communication and Stakeholder Engagement - Drafting effective Dear Healthcare Professional (DHCP) letters
- Preparing patient information leaflets and safety communications
- Engaging with patient advocacy groups on safety issues
- Presenting safety findings to internal governance boards
- Media relations during safety crises
- Communicating label changes and risk mitigation to sales teams
- Internal escalation pathways for critical safety events
- Global alignment of messaging across regions
- Handling inquiries from journalists and public bodies
- Psychological safety in team reporting and near-miss learning
Module 16: Career Advancement and Certification Readiness - Mapping course knowledge to recognized certification exams (e.g. RAC, DPA)
- Building a professional PV portfolio with templates and samples
- Highlighting PV expertise in performance reviews and job applications
- Negotiating salary increases using certification and project impact
- Transitioning into leadership roles: Safety Lead, PV Head, Global QPPV
- Networking strategies within global PV communities
- Contributing to industry guidelines and working groups
- Presenting at scientific meetings and publishing safety insights
- Continuous learning pathways beyond this course
- Final review and certification exam preparation guide
- Comparative analysis of EMA, FDA, PMDA, Health Canada, and TGA requirements
- Understanding EudraVigilance and FAERS architecture
- Mandatory reporting timelines for serious and non-serious ADRs
- Legal obligations for MAHs and third-party reporting entities
- Role of national competent authorities in signal validation
- EU pharmacovigilance legislation: Directive 2010/84/EU and Regulation (EU) No 1235/2010
- 21 CFR Part 310 and 314 requirements for US submissions
- CHMP Guideline on Good Pharmacovigilance Practices (GVP) overview
- Pharmacovigilance requirements in emerging markets (Latin America, Middle East, Southeast Asia)
- Handling regulatory expectations during post-authorization safety studies
Module 3: Case Processing and Individual Case Safety Reports (ICSRs) - Step-by-step workflow for initial case intake and triage
- Identifying reportability criteria: event seriousness, expectedness, and product relationship
- Source document evaluation: clinical notes, discharge summaries, and lab reports
- Data fields in ICH E2B(R3) and MedDRA coding essentials
- WHO Drug Dictionary (WHO-DD) coding principles
- Handling unstructured narratives and incomplete submissions
- Age, weight, and concomitant medication validation techniques
- Assessing patient follow-up requirements and data gap resolution
- Processing literature cases and handling conference abstracts
- Automation and data extraction tools for case processing efficiency
Module 4: Causality Assessment and Signal Detection Methodologies - Applying the Naranjo Algorithm for preliminary causality
- WHO-UMC causality grading: certain, probable, possible, unlikely
- Bradford Hill criteria for pharmacological causality evaluation
- Introduction to disproportionality analysis (PRR, ROR, IC)
- Signal detection using spontaneous reporting databases
- Setting thresholds for statistical signal generation
- Role of expert review panels in signal validation
- Integrating clinical context into statistical findings
- Signal assessment during outbreaks and public health emergencies
- Differentiating true signals from reporting bias and noise
Module 5: Risk Management Planning and Risk Minimization Strategies - Structure and content of the Risk Management Plan (RMP)
- Developing safety specifications, including SOIs and SOSs
- Designing pharmacovigilance planning (PVP) and post-authorization measures
- Creating REMS programs for FDA-regulated products
- Developing ESP, PASS, and PMCF as risk minimization tools
- Effectiveness checks for risk minimization materials
- User testing for patient medication guides and healthcare professional letters
- Designing safe dispensing and restricted distribution programs
- Incorporating patient registries into risk mitigation
- Balancing risk communication with market access needs
Module 6: Aggregate Reporting and Periodic Safety Updates - Structure and purpose of the PSUR and PBRER
- ICH E2C(R2) requirements for periodic reporting
- Data lock point selection and interval calculation methods
- Summary of Product Characteristics (SmPC) reconciliation process
- Benefit-risk evaluation frameworks in aggregate reporting
- Updating safety concerns and emerging risks in narratives
- Presenting tables and listings: AEs, laboratory abnormalities, mortality
- Handling orphan drugs and products with limited exposure
- Regional variations in PSUR submission formats (e.g. EU PSUR vs. US DSUR)
- Streamlining aggregate report production with standardized templates
Module 7: Pharmacovigilance in Clinical Development - Safety responsibilities during Phase I to Phase IV trials
- Designing safety monitoring plans for investigator-initiated studies
- Role of the Safety Monitoring Committee (SMC) and DSMBs
- Expedited reporting requirements for SUSARs
- ICH E2A guidelines for clinical safety data management
- Blinded review procedures and unblinding protocols
- Data Safety Monitoring Board (DSMB) reporting structures
- Integrating safety data across multiple trials
- Preparing clinical study reports (CSRs) with robust safety sections
- Handling protocol deviations related to safety events
Module 8: Literature Monitoring and Data Mining - Developing a systematic literature search strategy
- Using PubMed, Embase, and Google Scholar for safety data capture
- Automated alerts and keyword filtering for ongoing monitoring
- Validation of case reports found in scientific publications
- Handling case series and pooled analyses for signal detection
- Data mining open-source and preprint databases
- Assessing study quality and publication bias in safety findings
- Integrating literature findings into aggregate reports
- Managing duplicate reporting from clinical trials and literature
- Using AI-powered tools to enhance literature screening accuracy
Module 9: Global Safety Database Management - Key components of an effective safety database architecture
- Oracle Argus, ARISg, and Veeva Vault PV configuration best practices
- Data migration strategies from legacy systems
- Validation and audit-readiness of database queries
- Ensuring data integrity and ALCOA+ compliance
- Standardizing dictionary coding across multiple products
- Role of business continuity and disaster recovery in PV systems
- Interface management between safety databases and EDC systems
- Implementing role-based access controls (RBAC) for data security
- Database optimization for fast signal detection and reporting
Module 10: Inspections, Audits, and Quality Assurance - Preparing for EMA GVP inspections and FDA PQS audits
- Conducting internal PV system audits using risk-based approaches
- Documenting audit trails and data retention policies
- Responding to regulatory inspection findings and observations
- Designing corrective and preventive action (CAPA) plans
- Third-party vendor audits: CROs, call centers, and data processors
- Quality oversight in outsourced pharmacovigilance services
- Implementing continuous quality improvement (CQI) in PV
- Audit checklist development for PSMF and SOP compliance
- Training audit teams and preparing inspection response protocols
Module 11: Benefit-Risk Assessment and Decision Frameworks - Quantitative and qualitative methods in benefit-risk evaluation
- Using BRAT, EvaCAT, and other structured tools
- Incorporating patient perspectives into risk assessments
- Presenting benefit-risk to regulatory authorities and internal stakeholders
- Managing risk during public health emergencies (e.g. pandemic vaccines)
- Updating risk management based on new clinical evidence
- Handling therapeutic areas with high unmet medical need
- Communicating uncertainty in post-marketing safety profiles
- Decision trees for market suspension, label changes, or risk communication
- Aligning benefit-risk with health technology assessment (HTA) bodies
Module 12: Pharmacovigilance in Special Populations - Safety monitoring in pediatric populations
- Geriatric pharmacovigilance: polypharmacy and reporting challenges
- Drug safety in pregnancy and lactation (ICH E2B guidelines)
- Monitoring ADRs in oncology and immuno-oncology agents
- Cardiovascular safety signals and QT prolongation risks
- Hepatotoxicity and liver injury signal patterns
- Managing immune-mediated adverse reactions (irAEs)
- Psychiatric ADRs: suicidality, agitation, and cognitive effects
- Safety of biosimilars and complex generics
- Rare disease therapies: challenges in safety data collection
Module 13: Real-World Evidence and Post-Marketing Surveillance - Using electronic health records (EHR) for safety signal detection
- Leveraging claims databases and insurance data sources
- Designing post-authorization safety studies (PASS)
- Active surveillance using distributed data networks
- Propensity scoring and confounding adjustment in database studies
- Signal validation through targeted chart reviews
- Integrating social media and patient forums into surveillance (with caveats)
- Defining study endpoints for safety rather than efficacy
- Reporting real-world evidence findings to regulators
- Best practices for communicating RWE-based safety updates to HCPs
Module 14: Organizational Structures and PV System Oversight - Defining the role of the Qualified Person for Pharmacovigilance (QPPV)
- Establishing a pharmacovigilance department in a small biotech
- Centralized vs. decentralized PV operations in global firms
- Outsourcing PV to CROs: contracts, KPIs, and oversight
- Developing a pharmacovigilance system master file (PSMF)
- Annual review and update process for the PSMF
- Defining PV responsibilities across departments
- Implementing PV governance committees and SOPs
- Ensuring compliance across mergers, acquisitions, and product licensing
- Managing transitions during vendor or system changes
Module 15: Communication and Stakeholder Engagement - Drafting effective Dear Healthcare Professional (DHCP) letters
- Preparing patient information leaflets and safety communications
- Engaging with patient advocacy groups on safety issues
- Presenting safety findings to internal governance boards
- Media relations during safety crises
- Communicating label changes and risk mitigation to sales teams
- Internal escalation pathways for critical safety events
- Global alignment of messaging across regions
- Handling inquiries from journalists and public bodies
- Psychological safety in team reporting and near-miss learning
Module 16: Career Advancement and Certification Readiness - Mapping course knowledge to recognized certification exams (e.g. RAC, DPA)
- Building a professional PV portfolio with templates and samples
- Highlighting PV expertise in performance reviews and job applications
- Negotiating salary increases using certification and project impact
- Transitioning into leadership roles: Safety Lead, PV Head, Global QPPV
- Networking strategies within global PV communities
- Contributing to industry guidelines and working groups
- Presenting at scientific meetings and publishing safety insights
- Continuous learning pathways beyond this course
- Final review and certification exam preparation guide
- Applying the Naranjo Algorithm for preliminary causality
- WHO-UMC causality grading: certain, probable, possible, unlikely
- Bradford Hill criteria for pharmacological causality evaluation
- Introduction to disproportionality analysis (PRR, ROR, IC)
- Signal detection using spontaneous reporting databases
- Setting thresholds for statistical signal generation
- Role of expert review panels in signal validation
- Integrating clinical context into statistical findings
- Signal assessment during outbreaks and public health emergencies
- Differentiating true signals from reporting bias and noise
Module 5: Risk Management Planning and Risk Minimization Strategies - Structure and content of the Risk Management Plan (RMP)
- Developing safety specifications, including SOIs and SOSs
- Designing pharmacovigilance planning (PVP) and post-authorization measures
- Creating REMS programs for FDA-regulated products
- Developing ESP, PASS, and PMCF as risk minimization tools
- Effectiveness checks for risk minimization materials
- User testing for patient medication guides and healthcare professional letters
- Designing safe dispensing and restricted distribution programs
- Incorporating patient registries into risk mitigation
- Balancing risk communication with market access needs
Module 6: Aggregate Reporting and Periodic Safety Updates - Structure and purpose of the PSUR and PBRER
- ICH E2C(R2) requirements for periodic reporting
- Data lock point selection and interval calculation methods
- Summary of Product Characteristics (SmPC) reconciliation process
- Benefit-risk evaluation frameworks in aggregate reporting
- Updating safety concerns and emerging risks in narratives
- Presenting tables and listings: AEs, laboratory abnormalities, mortality
- Handling orphan drugs and products with limited exposure
- Regional variations in PSUR submission formats (e.g. EU PSUR vs. US DSUR)
- Streamlining aggregate report production with standardized templates
Module 7: Pharmacovigilance in Clinical Development - Safety responsibilities during Phase I to Phase IV trials
- Designing safety monitoring plans for investigator-initiated studies
- Role of the Safety Monitoring Committee (SMC) and DSMBs
- Expedited reporting requirements for SUSARs
- ICH E2A guidelines for clinical safety data management
- Blinded review procedures and unblinding protocols
- Data Safety Monitoring Board (DSMB) reporting structures
- Integrating safety data across multiple trials
- Preparing clinical study reports (CSRs) with robust safety sections
- Handling protocol deviations related to safety events
Module 8: Literature Monitoring and Data Mining - Developing a systematic literature search strategy
- Using PubMed, Embase, and Google Scholar for safety data capture
- Automated alerts and keyword filtering for ongoing monitoring
- Validation of case reports found in scientific publications
- Handling case series and pooled analyses for signal detection
- Data mining open-source and preprint databases
- Assessing study quality and publication bias in safety findings
- Integrating literature findings into aggregate reports
- Managing duplicate reporting from clinical trials and literature
- Using AI-powered tools to enhance literature screening accuracy
Module 9: Global Safety Database Management - Key components of an effective safety database architecture
- Oracle Argus, ARISg, and Veeva Vault PV configuration best practices
- Data migration strategies from legacy systems
- Validation and audit-readiness of database queries
- Ensuring data integrity and ALCOA+ compliance
- Standardizing dictionary coding across multiple products
- Role of business continuity and disaster recovery in PV systems
- Interface management between safety databases and EDC systems
- Implementing role-based access controls (RBAC) for data security
- Database optimization for fast signal detection and reporting
Module 10: Inspections, Audits, and Quality Assurance - Preparing for EMA GVP inspections and FDA PQS audits
- Conducting internal PV system audits using risk-based approaches
- Documenting audit trails and data retention policies
- Responding to regulatory inspection findings and observations
- Designing corrective and preventive action (CAPA) plans
- Third-party vendor audits: CROs, call centers, and data processors
- Quality oversight in outsourced pharmacovigilance services
- Implementing continuous quality improvement (CQI) in PV
- Audit checklist development for PSMF and SOP compliance
- Training audit teams and preparing inspection response protocols
Module 11: Benefit-Risk Assessment and Decision Frameworks - Quantitative and qualitative methods in benefit-risk evaluation
- Using BRAT, EvaCAT, and other structured tools
- Incorporating patient perspectives into risk assessments
- Presenting benefit-risk to regulatory authorities and internal stakeholders
- Managing risk during public health emergencies (e.g. pandemic vaccines)
- Updating risk management based on new clinical evidence
- Handling therapeutic areas with high unmet medical need
- Communicating uncertainty in post-marketing safety profiles
- Decision trees for market suspension, label changes, or risk communication
- Aligning benefit-risk with health technology assessment (HTA) bodies
Module 12: Pharmacovigilance in Special Populations - Safety monitoring in pediatric populations
- Geriatric pharmacovigilance: polypharmacy and reporting challenges
- Drug safety in pregnancy and lactation (ICH E2B guidelines)
- Monitoring ADRs in oncology and immuno-oncology agents
- Cardiovascular safety signals and QT prolongation risks
- Hepatotoxicity and liver injury signal patterns
- Managing immune-mediated adverse reactions (irAEs)
- Psychiatric ADRs: suicidality, agitation, and cognitive effects
- Safety of biosimilars and complex generics
- Rare disease therapies: challenges in safety data collection
Module 13: Real-World Evidence and Post-Marketing Surveillance - Using electronic health records (EHR) for safety signal detection
- Leveraging claims databases and insurance data sources
- Designing post-authorization safety studies (PASS)
- Active surveillance using distributed data networks
- Propensity scoring and confounding adjustment in database studies
- Signal validation through targeted chart reviews
- Integrating social media and patient forums into surveillance (with caveats)
- Defining study endpoints for safety rather than efficacy
- Reporting real-world evidence findings to regulators
- Best practices for communicating RWE-based safety updates to HCPs
Module 14: Organizational Structures and PV System Oversight - Defining the role of the Qualified Person for Pharmacovigilance (QPPV)
- Establishing a pharmacovigilance department in a small biotech
- Centralized vs. decentralized PV operations in global firms
- Outsourcing PV to CROs: contracts, KPIs, and oversight
- Developing a pharmacovigilance system master file (PSMF)
- Annual review and update process for the PSMF
- Defining PV responsibilities across departments
- Implementing PV governance committees and SOPs
- Ensuring compliance across mergers, acquisitions, and product licensing
- Managing transitions during vendor or system changes
Module 15: Communication and Stakeholder Engagement - Drafting effective Dear Healthcare Professional (DHCP) letters
- Preparing patient information leaflets and safety communications
- Engaging with patient advocacy groups on safety issues
- Presenting safety findings to internal governance boards
- Media relations during safety crises
- Communicating label changes and risk mitigation to sales teams
- Internal escalation pathways for critical safety events
- Global alignment of messaging across regions
- Handling inquiries from journalists and public bodies
- Psychological safety in team reporting and near-miss learning
Module 16: Career Advancement and Certification Readiness - Mapping course knowledge to recognized certification exams (e.g. RAC, DPA)
- Building a professional PV portfolio with templates and samples
- Highlighting PV expertise in performance reviews and job applications
- Negotiating salary increases using certification and project impact
- Transitioning into leadership roles: Safety Lead, PV Head, Global QPPV
- Networking strategies within global PV communities
- Contributing to industry guidelines and working groups
- Presenting at scientific meetings and publishing safety insights
- Continuous learning pathways beyond this course
- Final review and certification exam preparation guide
- Structure and purpose of the PSUR and PBRER
- ICH E2C(R2) requirements for periodic reporting
- Data lock point selection and interval calculation methods
- Summary of Product Characteristics (SmPC) reconciliation process
- Benefit-risk evaluation frameworks in aggregate reporting
- Updating safety concerns and emerging risks in narratives
- Presenting tables and listings: AEs, laboratory abnormalities, mortality
- Handling orphan drugs and products with limited exposure
- Regional variations in PSUR submission formats (e.g. EU PSUR vs. US DSUR)
- Streamlining aggregate report production with standardized templates
Module 7: Pharmacovigilance in Clinical Development - Safety responsibilities during Phase I to Phase IV trials
- Designing safety monitoring plans for investigator-initiated studies
- Role of the Safety Monitoring Committee (SMC) and DSMBs
- Expedited reporting requirements for SUSARs
- ICH E2A guidelines for clinical safety data management
- Blinded review procedures and unblinding protocols
- Data Safety Monitoring Board (DSMB) reporting structures
- Integrating safety data across multiple trials
- Preparing clinical study reports (CSRs) with robust safety sections
- Handling protocol deviations related to safety events
Module 8: Literature Monitoring and Data Mining - Developing a systematic literature search strategy
- Using PubMed, Embase, and Google Scholar for safety data capture
- Automated alerts and keyword filtering for ongoing monitoring
- Validation of case reports found in scientific publications
- Handling case series and pooled analyses for signal detection
- Data mining open-source and preprint databases
- Assessing study quality and publication bias in safety findings
- Integrating literature findings into aggregate reports
- Managing duplicate reporting from clinical trials and literature
- Using AI-powered tools to enhance literature screening accuracy
Module 9: Global Safety Database Management - Key components of an effective safety database architecture
- Oracle Argus, ARISg, and Veeva Vault PV configuration best practices
- Data migration strategies from legacy systems
- Validation and audit-readiness of database queries
- Ensuring data integrity and ALCOA+ compliance
- Standardizing dictionary coding across multiple products
- Role of business continuity and disaster recovery in PV systems
- Interface management between safety databases and EDC systems
- Implementing role-based access controls (RBAC) for data security
- Database optimization for fast signal detection and reporting
Module 10: Inspections, Audits, and Quality Assurance - Preparing for EMA GVP inspections and FDA PQS audits
- Conducting internal PV system audits using risk-based approaches
- Documenting audit trails and data retention policies
- Responding to regulatory inspection findings and observations
- Designing corrective and preventive action (CAPA) plans
- Third-party vendor audits: CROs, call centers, and data processors
- Quality oversight in outsourced pharmacovigilance services
- Implementing continuous quality improvement (CQI) in PV
- Audit checklist development for PSMF and SOP compliance
- Training audit teams and preparing inspection response protocols
Module 11: Benefit-Risk Assessment and Decision Frameworks - Quantitative and qualitative methods in benefit-risk evaluation
- Using BRAT, EvaCAT, and other structured tools
- Incorporating patient perspectives into risk assessments
- Presenting benefit-risk to regulatory authorities and internal stakeholders
- Managing risk during public health emergencies (e.g. pandemic vaccines)
- Updating risk management based on new clinical evidence
- Handling therapeutic areas with high unmet medical need
- Communicating uncertainty in post-marketing safety profiles
- Decision trees for market suspension, label changes, or risk communication
- Aligning benefit-risk with health technology assessment (HTA) bodies
Module 12: Pharmacovigilance in Special Populations - Safety monitoring in pediatric populations
- Geriatric pharmacovigilance: polypharmacy and reporting challenges
- Drug safety in pregnancy and lactation (ICH E2B guidelines)
- Monitoring ADRs in oncology and immuno-oncology agents
- Cardiovascular safety signals and QT prolongation risks
- Hepatotoxicity and liver injury signal patterns
- Managing immune-mediated adverse reactions (irAEs)
- Psychiatric ADRs: suicidality, agitation, and cognitive effects
- Safety of biosimilars and complex generics
- Rare disease therapies: challenges in safety data collection
Module 13: Real-World Evidence and Post-Marketing Surveillance - Using electronic health records (EHR) for safety signal detection
- Leveraging claims databases and insurance data sources
- Designing post-authorization safety studies (PASS)
- Active surveillance using distributed data networks
- Propensity scoring and confounding adjustment in database studies
- Signal validation through targeted chart reviews
- Integrating social media and patient forums into surveillance (with caveats)
- Defining study endpoints for safety rather than efficacy
- Reporting real-world evidence findings to regulators
- Best practices for communicating RWE-based safety updates to HCPs
Module 14: Organizational Structures and PV System Oversight - Defining the role of the Qualified Person for Pharmacovigilance (QPPV)
- Establishing a pharmacovigilance department in a small biotech
- Centralized vs. decentralized PV operations in global firms
- Outsourcing PV to CROs: contracts, KPIs, and oversight
- Developing a pharmacovigilance system master file (PSMF)
- Annual review and update process for the PSMF
- Defining PV responsibilities across departments
- Implementing PV governance committees and SOPs
- Ensuring compliance across mergers, acquisitions, and product licensing
- Managing transitions during vendor or system changes
Module 15: Communication and Stakeholder Engagement - Drafting effective Dear Healthcare Professional (DHCP) letters
- Preparing patient information leaflets and safety communications
- Engaging with patient advocacy groups on safety issues
- Presenting safety findings to internal governance boards
- Media relations during safety crises
- Communicating label changes and risk mitigation to sales teams
- Internal escalation pathways for critical safety events
- Global alignment of messaging across regions
- Handling inquiries from journalists and public bodies
- Psychological safety in team reporting and near-miss learning
Module 16: Career Advancement and Certification Readiness - Mapping course knowledge to recognized certification exams (e.g. RAC, DPA)
- Building a professional PV portfolio with templates and samples
- Highlighting PV expertise in performance reviews and job applications
- Negotiating salary increases using certification and project impact
- Transitioning into leadership roles: Safety Lead, PV Head, Global QPPV
- Networking strategies within global PV communities
- Contributing to industry guidelines and working groups
- Presenting at scientific meetings and publishing safety insights
- Continuous learning pathways beyond this course
- Final review and certification exam preparation guide
- Developing a systematic literature search strategy
- Using PubMed, Embase, and Google Scholar for safety data capture
- Automated alerts and keyword filtering for ongoing monitoring
- Validation of case reports found in scientific publications
- Handling case series and pooled analyses for signal detection
- Data mining open-source and preprint databases
- Assessing study quality and publication bias in safety findings
- Integrating literature findings into aggregate reports
- Managing duplicate reporting from clinical trials and literature
- Using AI-powered tools to enhance literature screening accuracy
Module 9: Global Safety Database Management - Key components of an effective safety database architecture
- Oracle Argus, ARISg, and Veeva Vault PV configuration best practices
- Data migration strategies from legacy systems
- Validation and audit-readiness of database queries
- Ensuring data integrity and ALCOA+ compliance
- Standardizing dictionary coding across multiple products
- Role of business continuity and disaster recovery in PV systems
- Interface management between safety databases and EDC systems
- Implementing role-based access controls (RBAC) for data security
- Database optimization for fast signal detection and reporting
Module 10: Inspections, Audits, and Quality Assurance - Preparing for EMA GVP inspections and FDA PQS audits
- Conducting internal PV system audits using risk-based approaches
- Documenting audit trails and data retention policies
- Responding to regulatory inspection findings and observations
- Designing corrective and preventive action (CAPA) plans
- Third-party vendor audits: CROs, call centers, and data processors
- Quality oversight in outsourced pharmacovigilance services
- Implementing continuous quality improvement (CQI) in PV
- Audit checklist development for PSMF and SOP compliance
- Training audit teams and preparing inspection response protocols
Module 11: Benefit-Risk Assessment and Decision Frameworks - Quantitative and qualitative methods in benefit-risk evaluation
- Using BRAT, EvaCAT, and other structured tools
- Incorporating patient perspectives into risk assessments
- Presenting benefit-risk to regulatory authorities and internal stakeholders
- Managing risk during public health emergencies (e.g. pandemic vaccines)
- Updating risk management based on new clinical evidence
- Handling therapeutic areas with high unmet medical need
- Communicating uncertainty in post-marketing safety profiles
- Decision trees for market suspension, label changes, or risk communication
- Aligning benefit-risk with health technology assessment (HTA) bodies
Module 12: Pharmacovigilance in Special Populations - Safety monitoring in pediatric populations
- Geriatric pharmacovigilance: polypharmacy and reporting challenges
- Drug safety in pregnancy and lactation (ICH E2B guidelines)
- Monitoring ADRs in oncology and immuno-oncology agents
- Cardiovascular safety signals and QT prolongation risks
- Hepatotoxicity and liver injury signal patterns
- Managing immune-mediated adverse reactions (irAEs)
- Psychiatric ADRs: suicidality, agitation, and cognitive effects
- Safety of biosimilars and complex generics
- Rare disease therapies: challenges in safety data collection
Module 13: Real-World Evidence and Post-Marketing Surveillance - Using electronic health records (EHR) for safety signal detection
- Leveraging claims databases and insurance data sources
- Designing post-authorization safety studies (PASS)
- Active surveillance using distributed data networks
- Propensity scoring and confounding adjustment in database studies
- Signal validation through targeted chart reviews
- Integrating social media and patient forums into surveillance (with caveats)
- Defining study endpoints for safety rather than efficacy
- Reporting real-world evidence findings to regulators
- Best practices for communicating RWE-based safety updates to HCPs
Module 14: Organizational Structures and PV System Oversight - Defining the role of the Qualified Person for Pharmacovigilance (QPPV)
- Establishing a pharmacovigilance department in a small biotech
- Centralized vs. decentralized PV operations in global firms
- Outsourcing PV to CROs: contracts, KPIs, and oversight
- Developing a pharmacovigilance system master file (PSMF)
- Annual review and update process for the PSMF
- Defining PV responsibilities across departments
- Implementing PV governance committees and SOPs
- Ensuring compliance across mergers, acquisitions, and product licensing
- Managing transitions during vendor or system changes
Module 15: Communication and Stakeholder Engagement - Drafting effective Dear Healthcare Professional (DHCP) letters
- Preparing patient information leaflets and safety communications
- Engaging with patient advocacy groups on safety issues
- Presenting safety findings to internal governance boards
- Media relations during safety crises
- Communicating label changes and risk mitigation to sales teams
- Internal escalation pathways for critical safety events
- Global alignment of messaging across regions
- Handling inquiries from journalists and public bodies
- Psychological safety in team reporting and near-miss learning
Module 16: Career Advancement and Certification Readiness - Mapping course knowledge to recognized certification exams (e.g. RAC, DPA)
- Building a professional PV portfolio with templates and samples
- Highlighting PV expertise in performance reviews and job applications
- Negotiating salary increases using certification and project impact
- Transitioning into leadership roles: Safety Lead, PV Head, Global QPPV
- Networking strategies within global PV communities
- Contributing to industry guidelines and working groups
- Presenting at scientific meetings and publishing safety insights
- Continuous learning pathways beyond this course
- Final review and certification exam preparation guide
- Preparing for EMA GVP inspections and FDA PQS audits
- Conducting internal PV system audits using risk-based approaches
- Documenting audit trails and data retention policies
- Responding to regulatory inspection findings and observations
- Designing corrective and preventive action (CAPA) plans
- Third-party vendor audits: CROs, call centers, and data processors
- Quality oversight in outsourced pharmacovigilance services
- Implementing continuous quality improvement (CQI) in PV
- Audit checklist development for PSMF and SOP compliance
- Training audit teams and preparing inspection response protocols
Module 11: Benefit-Risk Assessment and Decision Frameworks - Quantitative and qualitative methods in benefit-risk evaluation
- Using BRAT, EvaCAT, and other structured tools
- Incorporating patient perspectives into risk assessments
- Presenting benefit-risk to regulatory authorities and internal stakeholders
- Managing risk during public health emergencies (e.g. pandemic vaccines)
- Updating risk management based on new clinical evidence
- Handling therapeutic areas with high unmet medical need
- Communicating uncertainty in post-marketing safety profiles
- Decision trees for market suspension, label changes, or risk communication
- Aligning benefit-risk with health technology assessment (HTA) bodies
Module 12: Pharmacovigilance in Special Populations - Safety monitoring in pediatric populations
- Geriatric pharmacovigilance: polypharmacy and reporting challenges
- Drug safety in pregnancy and lactation (ICH E2B guidelines)
- Monitoring ADRs in oncology and immuno-oncology agents
- Cardiovascular safety signals and QT prolongation risks
- Hepatotoxicity and liver injury signal patterns
- Managing immune-mediated adverse reactions (irAEs)
- Psychiatric ADRs: suicidality, agitation, and cognitive effects
- Safety of biosimilars and complex generics
- Rare disease therapies: challenges in safety data collection
Module 13: Real-World Evidence and Post-Marketing Surveillance - Using electronic health records (EHR) for safety signal detection
- Leveraging claims databases and insurance data sources
- Designing post-authorization safety studies (PASS)
- Active surveillance using distributed data networks
- Propensity scoring and confounding adjustment in database studies
- Signal validation through targeted chart reviews
- Integrating social media and patient forums into surveillance (with caveats)
- Defining study endpoints for safety rather than efficacy
- Reporting real-world evidence findings to regulators
- Best practices for communicating RWE-based safety updates to HCPs
Module 14: Organizational Structures and PV System Oversight - Defining the role of the Qualified Person for Pharmacovigilance (QPPV)
- Establishing a pharmacovigilance department in a small biotech
- Centralized vs. decentralized PV operations in global firms
- Outsourcing PV to CROs: contracts, KPIs, and oversight
- Developing a pharmacovigilance system master file (PSMF)
- Annual review and update process for the PSMF
- Defining PV responsibilities across departments
- Implementing PV governance committees and SOPs
- Ensuring compliance across mergers, acquisitions, and product licensing
- Managing transitions during vendor or system changes
Module 15: Communication and Stakeholder Engagement - Drafting effective Dear Healthcare Professional (DHCP) letters
- Preparing patient information leaflets and safety communications
- Engaging with patient advocacy groups on safety issues
- Presenting safety findings to internal governance boards
- Media relations during safety crises
- Communicating label changes and risk mitigation to sales teams
- Internal escalation pathways for critical safety events
- Global alignment of messaging across regions
- Handling inquiries from journalists and public bodies
- Psychological safety in team reporting and near-miss learning
Module 16: Career Advancement and Certification Readiness - Mapping course knowledge to recognized certification exams (e.g. RAC, DPA)
- Building a professional PV portfolio with templates and samples
- Highlighting PV expertise in performance reviews and job applications
- Negotiating salary increases using certification and project impact
- Transitioning into leadership roles: Safety Lead, PV Head, Global QPPV
- Networking strategies within global PV communities
- Contributing to industry guidelines and working groups
- Presenting at scientific meetings and publishing safety insights
- Continuous learning pathways beyond this course
- Final review and certification exam preparation guide
- Safety monitoring in pediatric populations
- Geriatric pharmacovigilance: polypharmacy and reporting challenges
- Drug safety in pregnancy and lactation (ICH E2B guidelines)
- Monitoring ADRs in oncology and immuno-oncology agents
- Cardiovascular safety signals and QT prolongation risks
- Hepatotoxicity and liver injury signal patterns
- Managing immune-mediated adverse reactions (irAEs)
- Psychiatric ADRs: suicidality, agitation, and cognitive effects
- Safety of biosimilars and complex generics
- Rare disease therapies: challenges in safety data collection
Module 13: Real-World Evidence and Post-Marketing Surveillance - Using electronic health records (EHR) for safety signal detection
- Leveraging claims databases and insurance data sources
- Designing post-authorization safety studies (PASS)
- Active surveillance using distributed data networks
- Propensity scoring and confounding adjustment in database studies
- Signal validation through targeted chart reviews
- Integrating social media and patient forums into surveillance (with caveats)
- Defining study endpoints for safety rather than efficacy
- Reporting real-world evidence findings to regulators
- Best practices for communicating RWE-based safety updates to HCPs
Module 14: Organizational Structures and PV System Oversight - Defining the role of the Qualified Person for Pharmacovigilance (QPPV)
- Establishing a pharmacovigilance department in a small biotech
- Centralized vs. decentralized PV operations in global firms
- Outsourcing PV to CROs: contracts, KPIs, and oversight
- Developing a pharmacovigilance system master file (PSMF)
- Annual review and update process for the PSMF
- Defining PV responsibilities across departments
- Implementing PV governance committees and SOPs
- Ensuring compliance across mergers, acquisitions, and product licensing
- Managing transitions during vendor or system changes
Module 15: Communication and Stakeholder Engagement - Drafting effective Dear Healthcare Professional (DHCP) letters
- Preparing patient information leaflets and safety communications
- Engaging with patient advocacy groups on safety issues
- Presenting safety findings to internal governance boards
- Media relations during safety crises
- Communicating label changes and risk mitigation to sales teams
- Internal escalation pathways for critical safety events
- Global alignment of messaging across regions
- Handling inquiries from journalists and public bodies
- Psychological safety in team reporting and near-miss learning
Module 16: Career Advancement and Certification Readiness - Mapping course knowledge to recognized certification exams (e.g. RAC, DPA)
- Building a professional PV portfolio with templates and samples
- Highlighting PV expertise in performance reviews and job applications
- Negotiating salary increases using certification and project impact
- Transitioning into leadership roles: Safety Lead, PV Head, Global QPPV
- Networking strategies within global PV communities
- Contributing to industry guidelines and working groups
- Presenting at scientific meetings and publishing safety insights
- Continuous learning pathways beyond this course
- Final review and certification exam preparation guide
- Defining the role of the Qualified Person for Pharmacovigilance (QPPV)
- Establishing a pharmacovigilance department in a small biotech
- Centralized vs. decentralized PV operations in global firms
- Outsourcing PV to CROs: contracts, KPIs, and oversight
- Developing a pharmacovigilance system master file (PSMF)
- Annual review and update process for the PSMF
- Defining PV responsibilities across departments
- Implementing PV governance committees and SOPs
- Ensuring compliance across mergers, acquisitions, and product licensing
- Managing transitions during vendor or system changes
Module 15: Communication and Stakeholder Engagement - Drafting effective Dear Healthcare Professional (DHCP) letters
- Preparing patient information leaflets and safety communications
- Engaging with patient advocacy groups on safety issues
- Presenting safety findings to internal governance boards
- Media relations during safety crises
- Communicating label changes and risk mitigation to sales teams
- Internal escalation pathways for critical safety events
- Global alignment of messaging across regions
- Handling inquiries from journalists and public bodies
- Psychological safety in team reporting and near-miss learning
Module 16: Career Advancement and Certification Readiness - Mapping course knowledge to recognized certification exams (e.g. RAC, DPA)
- Building a professional PV portfolio with templates and samples
- Highlighting PV expertise in performance reviews and job applications
- Negotiating salary increases using certification and project impact
- Transitioning into leadership roles: Safety Lead, PV Head, Global QPPV
- Networking strategies within global PV communities
- Contributing to industry guidelines and working groups
- Presenting at scientific meetings and publishing safety insights
- Continuous learning pathways beyond this course
- Final review and certification exam preparation guide
- Mapping course knowledge to recognized certification exams (e.g. RAC, DPA)
- Building a professional PV portfolio with templates and samples
- Highlighting PV expertise in performance reviews and job applications
- Negotiating salary increases using certification and project impact
- Transitioning into leadership roles: Safety Lead, PV Head, Global QPPV
- Networking strategies within global PV communities
- Contributing to industry guidelines and working groups
- Presenting at scientific meetings and publishing safety insights
- Continuous learning pathways beyond this course
- Final review and certification exam preparation guide