TCS is hiring /n Role : SERM Scientist /n Qualification : BSC, B. Pharma, M. Pharma, Pharm D /n Location : Mumbai, Bangalore, Hyderabad, Pune, Delhi, NCR /n Roles &
Responsibilities /n Responsible for signal detection and evaluation activities for assigned products. /n • Ensures that accurate and fit-for-purpose evaluation documents with explicit conclusions are provided in response to /n internal or regulatory authority requests for safety data. /n • Assists in the production of Risk Management Plans (RMPs), Risk Tables for designated products, in consultation with /n Senior personnel. /n • Authors regulatory periodic reports and associated documentation globally according to the agreed process and /n timelines - reviews and contributes to production of program documents such as protocols and aggregate safety /n reports. /n /n
- Acts as a member of a process improvement initiative team within the GCSP.
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- Completes any post audit and inspection activities within the required timeline
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- Uses a range of sources and methods to gather information,
identifies and proposes potential solutions for
/n /n addressing issues or problems and making decisions with consultation of SERM physician. /n • Shows commitment to the task and effective time management to meet multiple deadlines successfully and with /n attention to detail and quality. Able to priorities own workload with minimal guidance. /n • Builds effective working relationships and responds to the needs of line functions in the matrix in relation to safety /n issues. /n • Supports safety governance or SRTs in the clinical development and post marketing settings by assisting in the /n establishment and operation of cross-functional teams in any SERM to detect and address product safety issues and /n ensures that risk-reduction strategies are implemented appropriately in clinical study protocols and or product /n labelling. /n Thanks & Regards /n Babeeta Shahi /n TCS – HR