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LeadershipL.RA.HPV
Head of PV
Leadership · Regulatory Authority
Leads the pharmacovigilance function within a regulatory authority.
Also known as: Head of Safety Surveillance
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
- Build and manage a high-growth PV team and communicate departmental information effectively to the team.
- Provide global strategic leadership by setting clear expectations and providing hands-on leadership for PV, promoting collaboration and team cohesiveness.
- Oversee all PV-related activities performed by external suppliers/consultants, ensure appropriate documentation and governance frameworks are in place
- Interact with internal and external staff to develop programs and processes to meet regulatory reporting requirements.
- Lead process improvement within global PV – including technology assessment and implementation.
- Collaborate with appropriate clinical, medical, quality, and regulatory counterparts to provide input and oversight for all safety and PV issues, as appropriate.
- Support relevant management staff.
- Oversee assessment of aggregate reporting, management of risk-benefit profiles for clinical and post-marketing compounds.
- Contribute to transparency and communication initiatives through the provision of scientifically rigorous and consistent information to promote the safe and effective use of medicines.
- Liaise with and provide technical information, advice and guidance on PV matters to other colleagues, pharmaceutical companies, relevant national and international bodies, healthcare professionals and members of the public.
- Support external compliance monitoring with PV obligations.
- Participate at all levels (internally and externally) in the formulation, and preparation of regulatory policies, guidelines, legislation, and opinions.
- Develop and implement relevant training.
- Ensure continuous improvement of resources and materials provided.
- Engage in continuous improvement of the processes.
- Support regulatory authority governance of ethic compliance and its implementation.
Overall required level: Expert.Draft competency standard for the Head of PV role. As a leadership role, expert-level command of PV governance, the PV system and applicable legislation is expected, together with strategic and people-leadership competencies. 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 |
|---|---|
| PV governance, strategy and the PV systemRef: EMA GVP Module I — Pharmacovigilance systems and their quality systems | Expert |
| PV legislation and GVP across regionsRef: Regulation (EC) No 726/2004; Directive 2001/83/EC | Expert |
| Risk management and aggregate reporting oversightRef: EMA GVP Module V (Rev 2); GVP Module VII | Expert |
| Audit, inspection readiness and CAPARef: EMA GVP Module III; GVP Module IV | Intermediate |
| Budgeting, resourcing and business continuity | Intermediate |
| Aggregate safety reports (PBRER/PSUR, DSUR)Ref: EMA GVP Module VII (PSUR); ICH E2C(R2) (PBRER); ICH E2F (DSUR) | Expert |
| Training, education and capacity buildingRef: WHO Pharmacovigilance Core Curriculum for University Teaching | Intermediate |
| Benefit–risk assessment methodologyRef: ICH E2C(R2) — Periodic Benefit-Risk Evaluation Report (PBRER) | Expert |
| PV policy, legislation and guideline developmentRef: Regulation (EC) No 726/2004; Directive 2001/83/EC | Expert |
Knowledge · Skills · Attitude
A summary of the competency elements expected for this role.
| Element | Knowledge | Skills | Attitude |
|---|---|---|---|
| Governance |
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| Compliance & inspections |
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| Leadership |
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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.
