UK QPPV
Leadership · Industry · Local QPPV
Establishes and maintains the UK PV system and acts as the single PV contact point for the MHRA.
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
- Resides and operate in the UK or EU/EAA.
- Responsible for establishing and maintaining the PV system.
- Act as a single PV contact point for MHRA regulators on a 24-hour basis and as a contact point for PV inspections.
- Ensure a tracking system for PV audits and related CAPA is in place and ensure implementation of such CAPA plans.
- Responsible for setting up a PV system that ensures accurately, timely, and complete submissions.
- Implement and evaluate local literature searches.
- Provide input into the preparation of regulatory action in response to emerging safety concerns (e.g., variations, urgent safety restrictions, communication to patients and healthcare professionals).
- Involved and consulted in due diligence that may have an impact on the PV system.
- Ownership of UK PSMFs.
- Responsible for ensuring suitable managed and up to date PV Business Continuity Plans that suitably covers the needs of the UK PSMF.
- Develop and implement relevant PV training.
- Ensure continuous improvement of resources and materials provided.
- Engage in continuous improvement of the processes.
- Support company governance of business ethic compliance and its implementation.
Overall required level: Expert.Draft competency standard for the UK QPPV 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 |
| Audits and regulatory inspectionsRef: EMA GVP Module IV — Pharmacovigilance audits (Rev 1); GVP Module III — Pharmacovigilance inspections | Expert |
| CAPA (corrective and preventive action) managementRef: EMA GVP Module IV — Pharmacovigilance audits (Rev 1) | Expert |
| Literature monitoring and reviewRef: EMA GVP Module VI (Rev 2) — literature monitoring | Intermediate |
| Training, education and capacity buildingRef: WHO Pharmacovigilance Core Curriculum for University Teaching | Intermediate |
| PSMF and Safety Data Exchange Agreements (SDEA)Ref: EMA GVP Module II — Pharmacovigilance system master file (Rev 2) | 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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