Job Description
TCS is hiring for
nRole: Aggregate Physician
nQualifications: MBBS, MD
nRoles & Responsibilities
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- Responsible 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 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 Senior personnel.n
- 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.n
- Acts as a member of a process improvement initiative team within the GCSP.n
- Completes any post audit and inspection activities within the required timelinen
- 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.n