Risk Management Scientist
Scientific · Industry · Risk Management
Performs safety analyses and contributes to development and maintenance of RMPs/REMS.
Also known as: PV and Risk Management 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
- Perform and contribute to safety analyses through review of case series, tabulated data and/or adverse event trend information.
- Contribute to document authoring, describing the evaluated safety data and assigned product(s).
- Perform and contribute with more senior scientists and safety physicians to signal detection activities and the signal management process.
- Collaborate with more senior scientists and safety physicians on risk management activities.
- Participate in the development and maintenance of RMPs/REMS.
- Participate in the review of medical/scientific literature to identify the literature relevant for signal detection activities and aggregate reporting.
- Participate in the preparation of aggregate safety reports.
- Contribute to the creation and maintenance of the RSI and company core labelling.
- Contribute, participate, and support Benefit-Risk Team meetings, including materials preparation, meeting minutes, and action item tracking.
- Contribute to a regulatory authority or other safety-related query responses.
- Participate in continuous process improvement projects and proactively identify and resolve issues related to safety risk management.
- Ensure that risk management documents are compliant with relevant regulatory requirements.
- Participate in inspection/audit related readiness activities and provide support for internal and external PV audits.
- Develop and deliver relevant training.
Overall required level: Intermediate.Draft competency standard for the Risk Management 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 |
|---|---|
| Risk management planning (GVP Module V): RMP structure and lifecycleRef: EMA GVP Module V — Risk management systems (Rev 2) | Expert |
| Risk minimisation measures and REMSRef: EMA GVP Module XVI — Risk minimisation measures (Rev 3) | Expert |
| Benefit–risk assessment methodologyRef: ICH E2C(R2) — Periodic Benefit-Risk Evaluation Report (PBRER) | Intermediate |
| Post-authorisation safety studies (PASS/PAES)Ref: EMA GVP Module VIII — Post-authorisation safety studies (Rev 3) | 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 |
| Audits and regulatory inspectionsRef: EMA GVP Module IV — Pharmacovigilance audits (Rev 1); GVP Module III — Pharmacovigilance inspections | 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 |
Knowledge · Skills · Attitude
A summary of the competency elements expected for this role.
| Element | Knowledge | Skills | Attitude |
|---|---|---|---|
| Risk planning |
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| Risk minimisation |
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| Benefit–risk |
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