SERM Scientist
Tata Consultancy Services · Bengaluru, Karnataka, India
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Tata Consultancy Services · Bengaluru, Karnataka, India
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.