Pharmacovigilance Toolkit

Downloadable Resources, Instant Access

Manage performance and development of staff and direct reports to ensure achievement of organizational and departmental goals and a productive work environment; manage and communicate performance and compensation related information per organization guidelines.

More Uses of the Pharmacovigilance Toolkit:

  • Manage adherence to all organization policies, SOPs, and other controlled documents; and ensure all programming activities adhere to departmental standards.

  • Contribute to Process Improvement and documentation/considerations on procedures; provide support for training to stakeholders.

  • Communicate with other stakeholders as Regulatory Affairs, Quality Assurance, Medical Affairs, Sales And Marketing among others.

  • Manage services cover the science and activities relating to the detection, assessment, understanding and prevention of adverse effects.

  • Ensure you instruct; lead and oversee and direct all aspects of Pharmacovigilance and Risk Management activities for development products and potential marketed products.

  • Confirm you mobilize; lead strategy and ensure development, implementation, and adoption of robust investigations and corrective/preventative action plans, and utilization of quality measures to drive Continuous Improvement.

  • Perform periodic review and summary of pertinent safety related literature and analysis of pre determined core signal data.

  • Serve as a key member of your team by developing Key Performance Indicators that follow your clients objectives and effectively supporting client deliverables and timelines.

  • Inform heads of Quality Management, heads of the assigned business line and Quality Assurance of quality issues according to SOPs.

  • Align activities and account plans to marketing programs and management direction in line with the Solution Selling model.

  • Arrange that your organization performs remote site qualification, site initiation, site monitoring calls, and close out visits ensuring regulatory, ICH GCP and protocol compliance.

  • Oversee and review reports on safety issues and implications for the Core Safety Information and Core Risk Minimization Activities.

  • Provide strategic and proActive Safety input into development plans Support Due Diligence activities and Pharmacovigilance agreements.

  • Secure that your organization communicates with investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.

  • Provide advice and support to relevant Key Stakeholders with regards to Quality Control, Risk Assessment, Risk Management and corrective/preventive actions.

  • Ensure compliance of relevant activities and quality documents, as signal detection activities and safety management activities.

  • Collect and provide meaningful medical insights back to the medical and commercial organizations to be actioned on in support of the strategy development.

  • Support interactions with, business partners (license partners) and vendors for all case intake and processing activities.

  • Ensure you accrue; lead safety signal management throughout product life cycle (detection, evaluation, validation, and development of Risk Management strategies).

  • Confirm your venture provides Pharmacovigilance functional area expertise and support to Project Teams for assigned developmental and/or marketed products.

  • Cooperate closely with the relevant Heads of business and other stakeholders, support maintaining focus on quality in project delivery.

  • Make sure that your planning performs duties in compliance with SOPs, GCP and Ich Guidelines in accordance with regulatory, legal and ethical standards.

  • Establish that your organization participates in the development and maintenance of Standard Operating Procedures (SOPs) and Work Instructions related to Data Management activities.

  • Deliver relevant marketing messages, product information and programs consistent with management direction in line with Solution Selling model.

  • Arrange that your operation
  • Provide documented ongoing safety surveillance and safety analysis of sponsored medical products and coordinate review in order to ensure compliance with Regulatory Requirements.

  • Develop mutually beneficial and productive long term partnerships with your customers based on high quality account plans.

  • Maintain high level of expertise with the evolving portfolio of products, services, pricing, competition, market and Industry Trends.

  • Contribute to the design, tracking and follow up of Risk Management plans for the products assigned and assure sound implementation.

  • Systematize: conduct Quality Management oversight of project deliverables to ensure that content is in accordance to the clients Business Objectives and expectation.


Save time, empower your teams and effectively upgrade your processes with access to this practical Pharmacovigilance Toolkit and guide. Address common challenges with best-practice templates, step-by-step Work Plans and maturity diagnostics for any Pharmacovigilance related project.

Download the Toolkit and in Three Steps you will be guided from idea to implementation results.

The Toolkit contains the following practical and powerful enablers with new and updated Pharmacovigilance specific requirements:

STEP 1: Get your bearings

Start with...

  • The latest quick edition of the Pharmacovigilance Self Assessment book in PDF containing 49 requirements to perform a quickscan, get an overview and share with stakeholders.

Organized in a Data Driven improvement cycle RDMAICS (Recognize, Define, Measure, Analyze, Improve, Control and Sustain), check the…

  • Example pre-filled Self-Assessment Excel Dashboard to get familiar with results generation

Then find your goals...

STEP 2: Set concrete goals, tasks, dates and numbers you can track

Featuring 999 new and updated case-based questions, organized into seven core areas of Process Design, this Self-Assessment will help you identify areas in which Pharmacovigilance improvements can be made.

Examples; 10 of the 999 standard requirements:

  1. How do you know that any Pharmacovigilance analysis is complete and comprehensive?

  2. Are all team members qualified for all tasks?

  3. How is the way you as the leader think and process information affecting your organizational culture?

  4. Are you able to realize any cost savings?

  5. How do you manage scope?

  6. How does your organization evaluate strategic Pharmacovigilance success?

  7. Is there any way to speed up the process?

  8. Do you have the optimal Project Management team structure?

  9. What Pharmacovigilance skills are most important?

  10. How do you recognize an Pharmacovigilance objection?

Complete the self assessment, on your own or with a team in a workshop setting. Use the workbook together with the self assessment requirements spreadsheet:

  • The workbook is the latest in-depth complete edition of the Pharmacovigilance book in PDF containing 994 requirements, which criteria correspond to the criteria in...

Your Pharmacovigilance self-assessment dashboard which gives you your dynamically prioritized projects-ready tool and shows your organization exactly what to do next:

  • The Self-Assessment Excel Dashboard; with the Pharmacovigilance Self-Assessment and Scorecard you will develop a clear picture of which Pharmacovigilance areas need attention, which requirements you should focus on and who will be responsible for them:

    • Shows your organization instant insight in areas for improvement: Auto generates reports, radar chart for maturity assessment, insights per process and participant and bespoke, ready to use, RACI Matrix
    • Gives you a professional Dashboard to guide and perform a thorough Pharmacovigilance Self-Assessment
    • Is secure: Ensures offline Data Protection of your Self-Assessment results
    • Dynamically prioritized projects-ready RACI Matrix shows your organization exactly what to do next:


STEP 3: Implement, Track, follow up and revise strategy

The outcomes of STEP 2, the self assessment, are the inputs for STEP 3; Start and manage Pharmacovigilance projects with the 62 implementation resources:

  • 62 step-by-step Pharmacovigilance Project Management Form Templates covering over 1500 Pharmacovigilance project requirements and success criteria:

Examples; 10 of the check box criteria:

  1. Cost Management Plan: Eac -estimate at completion, what is the total job expected to cost?

  2. Activity Cost Estimates: In which phase of the Acquisition Process cycle does source qualifications reside?

  3. Project Scope Statement: Will all Pharmacovigilance project issues be unconditionally tracked through the Issue Resolution process?

  4. Closing Process Group: Did the Pharmacovigilance project team have enough people to execute the Pharmacovigilance project plan?

  5. Source Selection Criteria: What are the guidelines regarding award without considerations?

  6. Scope Management Plan: Are Corrective Actions taken when actual results are substantially different from detailed Pharmacovigilance project plan (variances)?

  7. Initiating Process Group: During which stage of Risk planning are risks prioritized based on probability and impact?

  8. Cost Management Plan: Is your organization certified as a supplier, wholesaler, regular dealer, or manufacturer of corresponding products/supplies?

  9. Procurement Audit: Was a formal review of tenders received undertaken?

  10. Activity Cost Estimates: What procedures are put in place regarding bidding and cost comparisons, if any?

Step-by-step and complete Pharmacovigilance Project Management Forms and Templates including check box criteria and templates.

1.0 Initiating Process Group:

2.0 Planning Process Group:

  • 2.1 Pharmacovigilance Project Management Plan
  • 2.2 Scope Management Plan
  • 2.3 Requirements Management Plan
  • 2.4 Requirements Documentation
  • 2.5 Requirements Traceability Matrix
  • 2.6 Pharmacovigilance project Scope Statement
  • 2.7 Assumption and Constraint Log
  • 2.8 Work Breakdown Structure
  • 2.9 WBS Dictionary
  • 2.10 Schedule Management Plan
  • 2.11 Activity List
  • 2.12 Activity Attributes
  • 2.13 Milestone List
  • 2.14 Network Diagram
  • 2.15 Activity Resource Requirements
  • 2.16 Resource Breakdown Structure
  • 2.17 Activity Duration Estimates
  • 2.18 Duration Estimating Worksheet
  • 2.19 Pharmacovigilance project Schedule
  • 2.20 Cost Management Plan
  • 2.21 Activity Cost Estimates
  • 2.22 Cost Estimating Worksheet
  • 2.23 Cost Baseline
  • 2.24 Quality Management Plan
  • 2.25 Quality Metrics
  • 2.26 Process Improvement Plan
  • 2.27 Responsibility Assignment Matrix
  • 2.28 Roles and Responsibilities
  • 2.29 Human Resource Management Plan
  • 2.30 Communications Management Plan
  • 2.31 Risk Management Plan
  • 2.32 Risk Register
  • 2.33 Probability and Impact Assessment
  • 2.34 Probability and Impact Matrix
  • 2.35 Risk Data Sheet
  • 2.36 Procurement Management Plan
  • 2.37 Source Selection Criteria
  • 2.38 Stakeholder Management Plan
  • 2.39 Change Management Plan

3.0 Executing Process Group:

  • 3.1 Team Member Status Report
  • 3.2 Change Request
  • 3.3 Change Log
  • 3.4 Decision Log
  • 3.5 Quality Audit
  • 3.6 Team Directory
  • 3.7 Team Operating Agreement
  • 3.8 Team Performance Assessment
  • 3.9 Team Member Performance Assessment
  • 3.10 Issue Log

4.0 Monitoring and Controlling Process Group:

  • 4.1 Pharmacovigilance project Performance Report
  • 4.2 Variance Analysis
  • 4.3 Earned Value Status
  • 4.4 Risk Audit
  • 4.5 Contractor Status Report
  • 4.6 Formal Acceptance

5.0 Closing Process Group:

  • 5.1 Procurement Audit
  • 5.2 Contract Close-Out
  • 5.3 Pharmacovigilance project or Phase Close-Out
  • 5.4 Lessons Learned



With this Three Step process you will have all the tools you need for any Pharmacovigilance project with this in-depth Pharmacovigilance Toolkit.

In using the Toolkit you will be better able to:

  • Diagnose Pharmacovigilance projects, initiatives, organizations, businesses and processes using accepted diagnostic standards and practices
  • Implement evidence-based best practice strategies aligned with overall goals
  • Integrate recent advances in Pharmacovigilance and put Process Design strategies into practice according to best practice guidelines

Defining, designing, creating, and implementing a process to solve a business challenge or meet a business objective is the most valuable role; In EVERY company, organization and department.

Unless you are talking a one-time, single-use project within a business, there should be a process. Whether that process is managed and implemented by humans, AI, or a combination of the two, it needs to be designed by someone with a complex enough perspective to ask the right questions. Someone capable of asking the right questions and step back and say, 'What are we really trying to accomplish here? And is there a different way to look at it?'

This Toolkit empowers people to do just that - whether their title is entrepreneur, manager, consultant, (Vice-)President, CxO etc... - they are the people who rule the future. They are the person who asks the right questions to make Pharmacovigilance investments work better.

This Pharmacovigilance All-Inclusive Toolkit enables You to be that person.


Includes lifetime updates

Every self assessment comes with Lifetime Updates and Lifetime Free Updated Books. Lifetime Updates is an industry-first feature which allows you to receive verified self assessment updates, ensuring you always have the most accurate information at your fingertips.