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 (India)
🏢 Tata Consultancy Services
📍 India