PV Scientist
Scientific · Academia
Conducts pharmacovigilance science within an academic setting.
Also known as: Drug Safety Scientist, Safety Scientist
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
- Support safety surveillance, aggregate data review, and reporting activities.
- Use scientific expertise and medical background to integrate case-related information including medical conditions, lab results and procedures and effectively identify potential signals in collaboration with their manager and the safety physician/medical staff.
- On request assist in the preparation of safety-related sections and associated documentation for clinical and regulatory documents (including clinical study protocols, patient informed consent forms, clinical study final reports, annual reports, DSUR, integrated summaries of safety, RMPs and clinical expert reports).
- Participate in internal PV committee meetings and joint safety meetings with internal/external stakeholders.
- On request review the safety data reports for scientific accuracy and verify data against source documents.
- Contribute to the scientific literature by developing novel PV analytics, e.g., signal detection methods.
- Perform literature search and evaluation associated with signal investigations.
- Track events of special interest and safety commitments associated with aggregate reporting if applicable.
- Assist in the creation/revision of department procedures and policies.
- Develop and deliver relevant training.
Overall required level: Intermediate.Draft competency standard for the PV Scientist 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 curriculum and educational methodsRef: WHO Pharmacovigilance Core Curriculum for University Teaching | Expert |
| Pharmacovigilance science and research methodology | Intermediate |
| Regulatory framework and GVP overviewRef: EMA GVP Module I — Pharmacovigilance systems and their quality systems | Intermediate |
| Scientific writing and publication | Intermediate |
| Signal management process (GVP Module IX)Ref: EMA GVP Module IX — Signal management (Rev 1) | Intermediate |
| Aggregate safety reports (PBRER/PSUR, DSUR)Ref: EMA GVP Module VII (PSUR); ICH E2C(R2) (PBRER); ICH E2F (DSUR) | Intermediate |
| Literature monitoring and reviewRef: EMA GVP Module VI (Rev 2) — literature monitoring | Basic |
| Training, education and capacity buildingRef: WHO Pharmacovigilance Core Curriculum for University Teaching | Basic |
| Statistical, machine-learning and NLP methods for safety data | Intermediate |
Knowledge · Skills · Attitude
A summary of the competency elements expected for this role.
| Element | Knowledge | Skills | Attitude |
|---|---|---|---|
| Teaching |
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| Research |
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| Dissemination |
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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.
