TCS is hiring Role : SERM Physician Qualification : MBBS, MD Roles &

Responsibilities Responsible for signal detection and evaluation activities for assigned products.

- Ensures that accurate and fit-for-purpose evaluation documents with explicit conclusions are provided in response to internal or regulatory authority requests for safety data.
- Assists in the production of Risk Management Plans (RMPs), Risk Tables for designated products, in consultation with Senior personnel.
- Authors regulatory periodic reports and associated documentation globally according to the agreed process and timelines - reviews and contributes to production of program documents such as protocols and aggregate safety reports.
- 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 for addressing 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 with attention 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 safety issues.
- Supports safety governance or SRTs in the clinical development and post marketing settings by assisting in the establishment and operation of cross-functional teams in any SERM to detect and address product safety issues and ensures that risk-reduction strategies are implemented appropriately in clinical study protocols and or product labelling. Thanks & Regards Babeeta Shahi TCS – HR

📌 Aggregate Physician (Mumbai)
🏢 Tata Consultancy Services
📍 Mumbai