← Career Framework
ManagerialM.I.HMPV
Head of Medical PV
Managerial · Industry · Medical PV
Manages and supports medical and safety oversight and directs the Safety Management Team.
Also known as: Medical Director PV, Director Medical Writing
Draft
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
- Manage and support medical and safety oversight.
- Direct the Safety Management Team for the assigned project(s) or product(s) ensuring a safety and risk/benefit driven agenda from inception to closure.
- Represent Global DS at internal strategic and/or advisory/governance committees.
- May represent or act as an external technical resource at DSMB or Regulatory Authority meetings.
- Represent as a subject matter expert.
- Detect, validate, and manage pre-and/or post-approval safety signals through to resolution.
- Conduct a medical review of ICSR and analysis of AOSE as necessary, including the assessment of quality within the ICSR process; identify process improvement opportunities and drive changes in the process.
- Evaluate aggregate safety data and provide contributions to core regulatory documents i.e., PSUR, DSUR, RMPs, and other routine and non-routine safety and risk/benefit evaluations for internal or regulatory purposes as required.
- Identify, initiate, and manage to completion, necessary updates to the IB, CCSI and/or local product information, Medication Guide, Patient Leaflet, and other labelling documentation as necessary.
- Responsible for overseeing safety sections of documents and safety interactions with Regulatory authorities. This may include authorship of safety summaries to support changes to the PI/SmPC, significant contribution to MAAs and NDAs.
- Development of annual Medical Affairs strategy and plan in coordination with the departments.
- Management and continuous development of the Medical Affairs team.
- Planning, execution, supervision of medical projects.
- Coordination and medical responsibility for studies on a national level.
- 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 Medical PV 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 |
|---|---|
| Medical review of ICSRs: seriousness, expectedness, causalityRef: EMA GVP Module VI (Rev 2); ICH E2A — Clinical Safety Data Management | Expert |
| Benefit–risk assessment and safety scienceRef: ICH E2C(R2) — Periodic Benefit-Risk Evaluation Report (PBRER) | Intermediate |
| Aggregate report medical content and labellingRef: EMA GVP Module VII — Periodic safety update report | Intermediate |
| Clinical pharmacology and disease context | Intermediate |
| Signal management process (GVP Module IX)Ref: EMA GVP Module IX — Signal management (Rev 1) | Expert |
| Aggregate safety reports (PBRER/PSUR, DSUR)Ref: EMA GVP Module VII (PSUR); ICH E2C(R2) (PBRER); ICH E2F (DSUR) | Expert |
| Audits and regulatory inspectionsRef: EMA GVP Module IV — Pharmacovigilance audits (Rev 1); GVP Module III — Pharmacovigilance inspections | Expert |
| ICSR lifecycle: receipt, triage, data entry, quality controlRef: EMA GVP Module VI — Collection, management and submission of reports (Rev 2) | Expert |
| Training, education and capacity buildingRef: WHO Pharmacovigilance Core Curriculum for University Teaching | Intermediate |
| Budgeting, resourcing and business continuity | Expert |
| Benefit–risk assessment methodologyRef: ICH E2C(R2) — Periodic Benefit-Risk Evaluation Report (PBRER) | Expert |
Knowledge · Skills · Attitude
A summary of the competency elements expected for this role.
| Element | Knowledge | Skills | Attitude |
|---|---|---|---|
| Case assessment |
|
|
|
| Safety oversight |
|
|
|
| Communication |
|
|
|
Get certified for this role
Certification validates prerequisites via CV screening and assesses knowledge through an online, AI-proctored examination based on the competency standard. The latest terms and requirements for every role and region are maintained by the Institute of Pharmacovigilance.
