TCS is hiringRole : SERM ScientistQualification : BSC, B. Pharma, M. Pharma, Pharm DLocation : Mumbai, Bangalore, Hyderabad, Pune, Delhi, NCRRoles & ResponsibilitiesResponsible for signal detection and evaluation activities for assigned products.
- Ensures that accurate and fit-for-purpose evaluation documents with transparent conclusions are provided in response tointernal or regulatory authority requests for safety data.
- Assists in the production of Risk Management Plans (RMPs), Risk Tables for designated products, in consultation withSenior personnel.
- Authors regulatory periodic reports and associated documentation globally according to the agreed process andtimelines - reviews and contributes to production of program documents such as protocols and aggregate safetyreports.
- Acts as a member of a process improvement initiative team within the GCSP.
- Completes any post audit and inspection activities within the required timeline
- Uses a range of sources and methods to gather information,



identifies and proposes potential solutions foraddressing issues or problems and making decisions with consultation of SERM physician.
- Shows commitment to the task and effective time management to meet multiple deadlines successfully and withattention to detail and quality. Able to priorities own workload with minimal guidance.
- Builds effective working relationships and responds to the needs of line functions in the matrix in relation to safetyissues.
- Supports safety governance or SRTs in the clinical development and post marketing settings by assisting in theestablishment and operation of cross-functional teams in any SERM to detect and address product safety issues andensures that risk-reduction strategies are implemented appropriately in clinical study protocols and or productlabelling.Thanks & RegardsBabeeta ShahiTCS – HR

📌 Scientist (Maharashtra)
🏢 Tata Consultancy Services
📍 Maharashtra