| Detail | For this role |
|---|---|
| Department | Pharma |
| Level | Manager |
| Reports to | Head of Medical Affairs |
| Direct reports | Pharmacovigilance Scientist, Pharmacovigilance Associate |
| Experience | 8 to 12 years in pharmacovigilance, with team leadership experience |
Pharmacovigilance Manager 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 Manager
Department: Pharma
Reports to: Head of Medical Affairs
Location: [City], [office, branch or site]
About the role
A Pharmacovigilance Manager leads a pharmaceutical company's drug safety function. They oversee the collection, assessment and reporting of adverse events, manage safety databases and signal detection, ensure regulatory reporting deadlines are met, and keep the company compliant with pharmacovigilance rules. The role leads pharmacovigilance scientists and associates. A good one keeps every safety report accurate and on time, catches safety signals early, keeps the system inspection-ready, and makes sure the company meets its duty to monitor the safety of its medicines.
Key responsibilities
- Oversee the collection, processing and assessment of adverse event reports from all sources.
- Ensure individual case safety reports are assessed and submitted within regulatory timelines.
- Lead signal detection and the review of the safety profile of products.
- Prepare and review aggregate safety reports such as periodic safety update reports.
- Manage the safety database and keep case data accurate and complete.
- Lead and train pharmacovigilance scientists and associates on case handling.
- Keep the pharmacovigilance system compliant and ready for regulatory inspection.
- Maintain safety agreements and coordinate with partners and vendors.
- Respond to regulatory queries on safety and manage safety-related actions.
- Keep standard operating procedures and safety documentation current and audit-ready at all times.
Requirements
- Degree in pharmacy, medicine or life sciences
- Experience in pharmacovigilance or drug safety
- Knowledge of Indian and global safety regulations
- 8 to 12 years in pharmacovigilance, with team leadership experience
KRAs and KPIs for a Pharmacovigilance Manager
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 |
|---|---|
| Reporting timeliness | Safety reports submitted within regulatory timelines, with zero late submissions |
| Case quality | Adverse event cases assessed accurately, with few quality errors on review |
| Signal detection | Safety signals reviewed and escalated on schedule |
| Compliance | Pharmacovigilance system inspection-ready, with zero critical findings |
| Aggregate reports | Periodic safety reports delivered accurately by their due dates |
| Team capability | Scientists and associates trained and handling cases to standard |
Skills and tools
Tools used day to day: Safety database such as Argus, MedDRA dictionary, Regulatory reporting portals, MS Office, Literature databases.
Reporting line and career path
Next roles: Head of Pharmacovigilance, Head of Medical Affairs
Interview questions for a Pharmacovigilance Manager
- How do you make sure every serious adverse event is reported within the deadline?
- How do you approach signal detection for a product?
- How do you keep a pharmacovigilance system ready for inspection?
- A case was submitted late. How do you investigate and prevent it recurring?
- How do you assess the causality of an adverse event?
- How do you keep your team accurate under the pressure of reporting deadlines?
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What does a pharmacovigilance manager do?
A pharmacovigilance manager leads a pharma company's drug safety function. They oversee the collection, assessment and reporting of adverse events, manage safety databases and signal detection, ensure regulatory reporting deadlines are met, and keep the company compliant. They lead pharmacovigilance scientists and associates and keep the safety system inspection-ready.
What is pharmacovigilance in simple terms?
Pharmacovigilance is the science of monitoring the safety of medicines after they reach patients. Companies collect reports of side effects and adverse events, assess them, look for safety signals, and report to regulators within strict deadlines. It is how the industry keeps track of whether a medicine is causing unexpected harm.
What qualifications do you need for pharmacovigilance?
Most pharmacovigilance professionals hold a degree in pharmacy, medicine or life sciences. Managers add several years of drug safety experience and knowledge of Indian and global safety regulations. Attention to detail and medical understanding are essential, since the work involves assessing adverse events accurately and meeting legally fixed reporting deadlines.