PV Policy Lead
Leadership · Regulatory Authority
Coordinates and disseminates PV policy across teams within a regulatory authority.
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
- Coordinate the exchange of policy-related information and disseminate it across other teams, and ensure all the resources provided are available to implement relevant policies.
- Maintain regular contact with other divisions and give feedback with regards to policy-related changes for the successful enforcement of the policies.
- Support relevant management staff.
- Engage with Training and Quality teams regularly to ensure robust and consistent enforcement and correct understanding of internal policies.
- Flag resource constraints, policy issues or inconsistencies timely.
- Gather insights and offer policy suggestions based on the direct application of the policies.
- 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 relevant PV matters to other regulatory 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.
- 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 PV Policy Lead 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 |
| Training, education and capacity buildingRef: WHO Pharmacovigilance Core Curriculum for University Teaching | Intermediate |
| 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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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.
