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ScientificS.RA.SA
PV Scientific Assessor
Scientific · Regulatory Authority
Performs scientific assessment of PV data within a regulatory authority.
Also known as: PV Scientific Officer
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
- Review and evaluation of adverse reaction data.
- Work with other staff to facilitate changes to safety reporting requirements arising from revisions to clinical trials legislation.
- Liaise with and provide technical information, advice, and guidance on PV matters.
- Support the PV Medical Assessor and other staff.
- Prepare and compile PV data for review and draft of reports.
- Contribute to the review and analysis of adverse reaction reporting trends.
- Contribute to the preparation of PV related publications.
- Assist in the implementation and maintenance of quality management in the PV section, including identifying potential problems and providing solutions in a timely manner.
- Ensure accurate and consistent use of nomenclatures and coding standards/requirements.
- Ensure appropriate maintenance and management of adverse reaction data.
- Assist with the effective implementation of the NRA quality management system within the department.
- Assist the Management team to ensure that PV section procedures remain consistent with relevant developments in national and international regulations, legislation, and guidelines.
- 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 Scientific Assessor 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 |
| MedDRA and WHODrug coding conventionsRef: MedDRA (MedDRA MSSO); WHODrug (Uppsala Monitoring Centre) | 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 |
| PV quality management system (GVP Module I)Ref: EMA GVP Module I — Pharmacovigilance systems and their quality systems | 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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