EU QPPV
Leadership · Industry · Regional QPPV
Qualified Person Responsible for Pharmacovigilance residing and operating in the EU/EEA, the single PV contact point for the EMA and member-state authorities.
Also known as: Qualified Person Responsible for Pharmacovigilance (EU)
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
- Reside and operate in the EU/EEA.
- Act as a single PV contact point for competent authorities in the member states and the EMA on a 24-hour basis, as well as a contact point for PV inspections.
- Responsible for the establishment and maintenance of the EU PV system in accordance with EU legislation and associated guidance documents.
- Have oversight of the functioning of the PV system in all relevant aspects, including its quality system.
- Have an overview and awareness of medicinal product safety profiles and of conditions or obligations adopted as part of the marketing authorisations.
- Have sufficient authority over the content of risk management plans.
- Be involved in the review and sign-off of protocols of post-authorisation safety studies conducted in the EU.
- Ensure submission of PV-related documents in accordance with legal requirements and ensure the necessary quality, correctness and completeness of PV data.
- Ensure full and prompt responses to any request from competent authorities in the member states and the EMA.
- Maintain a matrix of local QPPVs and equivalents (in-house and outsourced) across all EU countries.
Overall required level: Expert.The EU QPPV is expected to hold expert-level knowledge of EU pharmacovigilance legislation, the PV system and its quality system, with authority over risk management and post-authorisation safety activities in the EU/EEA.
Prerequisites
Mandatory prerequisites
- →Residence in the EU/EEA
- →University degree in a relevant life-science discipline
- →Demonstrated experience in EU pharmacovigilance
Recommendations
- →Working proficiency in English
- →Familiarity with EudraVigilance and PSMF maintenance
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 |
|---|---|
| EU pharmacovigilance legislation (Directive 2001/83/EC, Regulation (EC) No 726/2004) | Expert |
| Good Pharmacovigilance Practices (GVP) modules | Expert |
| Pharmacovigilance System Master File (PSMF) | Expert |
| Quality system requirements for the PV system | Expert |
Regional Regulatory Specific Knowledge
EU/EEA variant.
| Topic | Level |
|---|---|
| EMA and national competent authority interactions | Expert |
| EudraVigilance and ICSR reporting obligations | Intermediate |
| PRAC procedures and referrals | Intermediate |
Role-Specific Knowledge
| Topic | Level |
|---|---|
| Risk management plans (RMPs) and risk minimisation | Expert |
| Post-authorisation safety studies (PASS/PAES) | Intermediate |
| Aggregate reporting (PSUR/PBRER) | Intermediate |
| Signal management in the EU regulatory context | Intermediate |
Knowledge · Skills · Attitude
A summary of the competency elements expected for this role.
| Element | Knowledge | Skills | Attitude |
|---|---|---|---|
| EU PV system oversight |
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| Authority interactions |
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| Product safety authority |
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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.
