| Detail | For this role |
|---|---|
| Department | Pharma |
| Level | Mid level |
| Reports to | Pharmacovigilance Manager |
| Direct reports | None |
| Experience | 2 to 5 years in pharmacovigilance or drug safety |
Pharmacovigilance Scientist job description template
Copy this job description, replace the text in square brackets and post it on your careers page or a job portal.
Job title: Pharmacovigilance Scientist
Department: Pharma
Reports to: Pharmacovigilance Manager
Location: [City], [office, branch or site]
About the role
A Pharmacovigilance Scientist processes and assesses reports of adverse events to help monitor the safety of medicines. They enter and evaluate cases, judge causality and seriousness, code events, contribute to aggregate reports and signal reviews, and make sure cases meet regulatory standards. The role sits in the drug safety team under a pharmacovigilance manager. A good one processes cases accurately and on time, applies sound medical judgement to each event, keeps quality high under deadline pressure, and helps the company meet its safety reporting duties.
Key responsibilities
- Receive, enter and process individual case safety reports from all sources.
- Assess each adverse event for seriousness, expectedness and causality.
- Code adverse events and drugs using the MedDRA dictionary correctly.
- Write accurate case narratives and complete cases within regulatory timelines.
- Contribute to aggregate safety reports and periodic safety updates.
- Support signal detection by reviewing case and safety data.
- Perform quality checks on cases and correct errors before submission.
- Follow up with reporters to gather missing case information.
- Keep case documentation complete and the safety database accurate.
- Follow standard operating procedures and pharmacovigilance regulations on every case handled.
Requirements
- Degree in pharmacy, life sciences or medicine
- Training or experience in pharmacovigilance
- Knowledge of safety reporting standards
- 2 to 5 years in pharmacovigilance or drug safety
KRAs and KPIs for a Pharmacovigilance Scientist
Key result areas for the appraisal form, each with a KPI you can measure every month or quarter.
| Key result area | How to measure it |
|---|---|
| Case timeliness | Cases processed and submitted within regulatory timelines, with zero late cases |
| Case quality | Cases accurate on assessment and coding, with few quality errors on review |
| Narrative quality | Case narratives clear, complete and consistent with the data |
| Aggregate contribution | Contributions to aggregate reports delivered accurately on schedule |
| Data accuracy | Safety database entries complete and accurate |
| Compliance | Full compliance with procedures and pharmacovigilance regulations |
Skills and tools
Tools used day to day: Safety database such as Argus, MedDRA dictionary, WHO drug dictionary, MS Office, Regulatory reporting portals.
Reporting line and career path
Next roles: Senior Pharmacovigilance Scientist, Pharmacovigilance Manager
Interview questions for a Pharmacovigilance Scientist
- How do you assess the causality of an adverse event?
- What makes an adverse event serious under the regulations?
- How do you write a clear case narrative from incomplete information?
- How do you keep case quality high when deadlines are tight?
- How do you code an event correctly in MedDRA?
- What do you do when a case is missing key information?
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What does a pharmacovigilance scientist do?
A pharmacovigilance scientist processes and assesses reports of adverse events to help monitor the safety of medicines. They enter and evaluate cases, judge causality and seriousness, code events, write narratives, and contribute to aggregate reports and signal reviews. They process cases accurately and within the strict regulatory timelines that safety reporting demands.
What is the difference between a pharmacovigilance scientist and associate?
A pharmacovigilance associate is usually the entry role, doing case intake, data entry and basic processing. A pharmacovigilance scientist takes on fuller case assessment, causality judgement, narratives and aggregate report contributions, with more medical judgement and responsibility. The associate learns the basics; the scientist handles more complex safety work.
What qualifications do you need for pharmacovigilance?
Most pharmacovigilance scientists hold a degree in pharmacy, life sciences or medicine, plus training or experience in drug safety. Knowledge of safety reporting standards, MedDRA coding and causality assessment matters. Attention to detail and the ability to keep quality high under strict deadlines are what set a strong pharmacovigilance scientist apart.