Head of PV Inspectorate
Managerial · Regulatory Authority · Inspectorate
Leads the PV inspectorate, ensuring appropriate objectives, analytics and targets.
Also known as: Head of PV Audits & Inspections
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
- Ensure appropriate objectives, analytics, and targets are in use to drive performance and that these are incorporated into the management plans of the individual teams within the department.
- Ensure that the department has the required technical, managerial, investigative, and operational skills; and that the department’s processes and practices are supported by appropriate standards, policies, and guidelines.
- Lead quality improvement in terms of reviewing processes and making these more efficient, smarter, and informed by experience.
- Lead the department’s participation in the identification and implementation of change initiatives required to enhance the organisation’s approach to risk management and inspections, authorisations, and investigations.
- Responsible for representing the regulatory authority on relevant regulatory activities within the department’s remit.
- Represent the regulatory authority at the country and international level as required.
- 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.
- Propose process improvements.
- 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 PV Inspectorate 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 |
|---|---|
| PV inspection methodology and planningRef: EMA GVP Module III — Pharmacovigilance inspections | Expert |
| GVP compliance requirements and legislationRef: EMA GVP Module I; Regulation (EC) No 726/2004 | Expert |
| Risk-based inspection and CAPA evaluationRef: EMA GVP Module III — Pharmacovigilance inspections | Intermediate |
| Inspection reporting and evidence standardsRef: EMA GVP Module III — Pharmacovigilance inspections | Intermediate |
| Risk management planning (GVP Module V): RMP structure and lifecycleRef: EMA GVP Module V — Risk management systems (Rev 2) | Expert |
| Audits and regulatory inspectionsRef: EMA GVP Module IV — Pharmacovigilance audits (Rev 1); GVP Module III — Pharmacovigilance inspections | Expert |
| 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 |
| Statistical, machine-learning and NLP methods for safety data | Expert |
Knowledge · Skills · Attitude
A summary of the competency elements expected for this role.
| Element | Knowledge | Skills | Attitude |
|---|---|---|---|
| Inspection |
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| Compliance evaluation |
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| Reporting |
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