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
Perk-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.