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
Advantage-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