SERM Scientist
Tata Consultancy Services
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Job summary
Tata Consultancy Services in Bengaluru seeks a SERM Scientist (Safety Evaluation & Risk Management) with 3+ years of pharmacovigilance experience to drive signal detection, safety evaluation, and regulatory safety reporting for assigned products.
You will prepare and review RMPs, author PSUR/PBRER/DSUR reports, analyze safety data, and support safety governance with cross-functional teams to ensure global regulatory compliance.
Qualifications
- B.Pharm, M.Pharm, Pharm.D or related health sciences degree required.
- 3+ years of Pharmacovigilance experience.
- Experience with regulatory safety reporting and PV signal detection.
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.
Skills
Education
Job description
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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