Head of PV Pharmacoepidemiology
Managerial · Industry · Pharmacoepidemiology
Serves as the strategic lead for epidemiologic support of approved and developmental drugs.
This competency standard is a working draft prepared for reviewand is not yet an official GPPC standard. Content is derived from the role’s job description and established pharmacovigilance practice, and is subject to change.
Job description
- Contribute to the vision and operationalization of the pharmacoepidemiology group.
- Serve as the strategic lead for epidemiologic support of drugs, approved and in development, including conducting reviews of the epidemiology of indications and adverse events, analyse of datasets, and designing and executing new studies.
- Prioritize activities across multiple projects and effectively negotiate plans with colleagues and customers.
- Take on the responsibility for professional development of self and share accountability for the achievement of department-wide goals and objectives.
- Participate in inspection/audit related readiness activities and provide support for internal and external PV audits.
- Engage in continuous improvement of relevant processes.
- Provide adequate support, motivation, encouragement, and effective management for all relevant staff.
- Develop and implement relevant training.
Overall required level: Expert.Draft competency standard for the Head of PV Pharmacoepidemiology role. As a managerial role, expert-level knowledge of the managed function and strong oversight, compliance and people-management competencies are expected. Levels are an initial proposal derived from the role's job description and typical pharmacovigilance practice, pending expert review.
Prerequisites
Mandatory prerequisites
- →University degree in medicine, pharmacy, life sciences or a related discipline
- →Relevant pharmacovigilance experience appropriate to the role
Recommendations
- →Working proficiency in English
- →Familiarity with the applicable GVP modules
Concept of levels
Knowledge for each topic is assessed on a four-level scale.
| Level | Expected knowledge |
|---|---|
| N/A | No knowledge required. |
| Basic | Elementary knowledge of the specific regulation; fundamental understanding of the terms and definitions used, a basic understanding of the concept of the regulation, a general overview of what it covers and where it can be found; passive/delegated usage of the regulation. |
| Intermediate | Very good knowledge of the specific regulation; comprehensive understanding of the terms and definitions and of the concept and context of who/when/where/why/how it applies; active usage of the regulation when required. |
| Expert | Excellent knowledge of the specific regulation; in-depth understanding of the concept and of how and why its sections should be implemented and followed, including outcomes and responsibilities for all relevant stakeholders; active usage of the regulation on a daily basis. |
Knowledge
General Knowledge
| Topic | Level |
|---|---|
| Pharmacovigilance principles and Good Pharmacovigilance Practices (GVP) overviewRef: EMA GVP Module I — Pharmacovigilance systems and their quality systems; EU Reg (EC) 726/2004 & Dir 2001/83/EC | Expert |
| The pharmacovigilance system and Pharmacovigilance System Master File (PSMF)Ref: EMA GVP Module II — Pharmacovigilance system master file (Rev 2) | Expert |
| Individual case safety report (ICSR) management and regulatory reporting timelinesRef: EMA GVP Module VI (Rev 2); ICH E2D(R1); ICH E2B(R3) | Expert |
Role-Specific Knowledge
Includes topics derived from this role's job description.
| Topic | Level |
|---|---|
| Pharmacoepidemiology study design (PASS/PAES)Ref: EMA GVP Module VIII (Rev 3); ENCePP Guide on Methodological Standards | Expert |
| Real-world evidence (RWE) and data sourcesRef: ENCePP Guide on Methodological Standards in Pharmacoepidemiology | Intermediate |
| Biostatistics and study analysis | Intermediate |
| GVP Module VIII (post-authorisation safety studies)Ref: EMA GVP Module VIII — Post-authorisation safety studies (Rev 3) | Intermediate |
| Audits and regulatory inspectionsRef: EMA GVP Module IV — Pharmacovigilance audits (Rev 1); GVP Module III — Pharmacovigilance inspections | Expert |
| Training, education and capacity buildingRef: WHO Pharmacovigilance Core Curriculum for University Teaching | Intermediate |
| Post-authorisation safety studies (PASS/PAES)Ref: EMA GVP Module VIII — Post-authorisation safety studies (Rev 3) | Expert |
Knowledge · Skills · Attitude
A summary of the competency elements expected for this role.
| Element | Knowledge | Skills | Attitude |
|---|---|---|---|
| Study design |
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| Analysis |
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| Evidence |
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