TCS is hiring

nRole : SERM Scientist

nQualification : BSC, B. Pharma, M. Pharma, Pharm D

nLocation : Mumbai, Bangalore, Hyderabad, Pune, Delhi, NCR

nRoles & Responsibilities

nResponsible for signal detection and evaluation activities for assigned products.

n• Ensures that accurate and fit-for-purpose evaluation documents with transparent conclusions are provided in response to

ninternal 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

nSenior personnel.

n• Authors regulatory periodic reports and associated documentation globally according to the agreed process and

ntimelines - reviews and contributes to production of program documents such as protocols and aggregate safety

nreports.

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
n
Uses a range of sources and methods to gather information,



identifies and proposes potential solutions for
n

naddressing 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

nattention 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

nissues.

n• Supports safety governance or SRTs in the clinical development and post marketing settings by assisting in the

nestablishment and operation of cross-functional teams in any SERM to detect and address product safety issues and

nensures that risk-reduction strategies are implemented appropriately in clinical study protocols and or product

nlabelling.

nThanks & Regards

nBabeeta Shahi

nTCS – HR

📌 Scientist Mumbai (India)
🏢 Tata Consultancy Services
📍 India