Role: SERM Scientist (Safety Evaluation & Risk Management)
Experience: 3+ Years
Education: B.Pharm, M.Pharm, Pharm.D, BSc/MSc Life Sciences, Nursing, MBBS or related Health Sciences degree.
Key Skills:
- Pharmacovigilance (PV)
- Signal Detection & Evaluation
- Risk Management Plans (RMP)
- PSUR/PBRER/DSUR
- Safety Data Analysis
- Benefit-Risk Assessment
- Regulatory Safety Reporting
- Post-Marketing Surveillance
Responsibilities:
- Perform signal detection and safety evaluation for assigned products.
- Prepare and review Risk Management Plans (RMPs).
- Author and support aggregate reports (PSUR, PBRER, DSUR).
- Analyze safety data and identify potential risks.
- Support safety governance and cross-functional safety teams.
- Ensure compliance with global regulatory requirements.
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