Job Description
Role: SERM Scientist (Safety Evaluation & Risk Management)
nExperience: 3+ Years
nEducation: B.Pharm, M.Pharm, Pharm.D, BSc/MSc Life Sciences, Nursing, MBBS or related Health Sciences degree.
nKey Skills:
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- Pharmacovigilance (PV)n
- Signal Detection & Evaluationn
- Risk Management Plans (RMP)n
- PSUR/PBRER/DSURn
- Safety Data Analysisn
- Benefit-Risk Assessmentn
- Regulatory Safety Reportingn
- Post-Marketing Surveillancen
nResponsibilities:
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- Perform signal detection and safety evaluation for assigned products.n
- Prepare and review Risk Management Plans (RMPs).n
- Author and support aggregate reports (PSUR, PBRER, DSUR).n
- Analyze safety data and identify potential risks.n
- Support safety governance and cross-functional safety teams.n
- Ensure compliance with global regulatory requirements.n