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ScientificS.RA.INSP
PV Inspector
Scientific · Regulatory Authority
Conducts pharmacovigilance inspections on behalf of a regulatory authority.
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
- Evaluate the compliance of sites inspected, with the requirements of national legislation.
- Prepare for, organize, and carry out inspections in accordance with NRA and all relevant procedures.
- Evaluate complex information, identify relevant standards, and assess compliance with relevant requirements.
- Compile inspection reports when acting as a lead inspector, contribute to the preparation of reports for joint or accompanied inspections.
- Assist in the compilation of data and preparation of management reports as required.
- Apply risk management principles.
- Submit reports as required and maintain appropriate records of meetings and activities.
- Ensure a database of inspection details is maintained.
- Assist in the introduction of new legislation, and development of policy and practice guidelines and procedures.
- Provide support to other areas of the NRA where appropriate.
- Assist the management team to ensure that effective mechanisms are in place to capture, store and communicate information, experience and knowledge gained.
- Assist the management team in ensuring that available information and knowledge across the regulatory authority is effectively used by the Inspection section.
- Assist the management team to ensure that inspection procedures remain up to date with relevant developments in national and international regulations, legislation, and guides.
- Participate and represent at national and international seminars in PV inspections.
- Respond to queries (technical and procedural) from internal and external customers.
- 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.
- Develop and deliver relevant training.
Overall required level: Intermediate.Draft competency standard for the PV Inspector role. As a scientific role, intermediate-to-expert command of the relevant scientific domain and its regulatory context is 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 | Intermediate |
| The pharmacovigilance system and Pharmacovigilance System Master File (PSMF)Ref: EMA GVP Module II — Pharmacovigilance system master file (Rev 2) | Intermediate |
| Individual case safety report (ICSR) management and regulatory reporting timelinesRef: EMA GVP Module VI (Rev 2); ICH E2D(R1); ICH E2B(R3) | Intermediate |
Role-Specific Knowledge
Includes topics derived from this role's job description.
| Topic | Level |
|---|---|
| PV legislation and regulatory assessment proceduresRef: Regulation (EC) No 726/2004; Directive 2001/83/EC | Expert |
| Assessment of causality, signals and aggregate dataRef: EMA GVP Module IX; GVP Module VII | Expert |
| Regulatory action and risk communicationRef: EMA GVP Module XV — Safety communication (Rev 1) | Intermediate |
| Nomenclature and coding standardsRef: MedDRA (MedDRA MSSO); ISO IDMP standards | Intermediate |
| Risk management planning (GVP Module V): RMP structure and lifecycleRef: EMA GVP Module V — Risk management systems (Rev 2) | Intermediate |
| Audits and regulatory inspectionsRef: EMA GVP Module IV — Pharmacovigilance audits (Rev 1); GVP Module III — Pharmacovigilance inspections | Intermediate |
| Safety database administration and configurationRef: ICH E2B(R3); EMA EudraVigilance | Intermediate |
| Training, education and capacity buildingRef: WHO Pharmacovigilance Core Curriculum for University Teaching | Basic |
| PV policy, legislation and guideline developmentRef: Regulation (EC) No 726/2004; Directive 2001/83/EC | Intermediate |
Knowledge · Skills · Attitude
A summary of the competency elements expected for this role.
| Element | Knowledge | Skills | Attitude |
|---|---|---|---|
| Assessment |
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| Regulatory action |
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| Communication |
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