Job DescriptionTCS 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 explicit 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 timeline N
- Uses a range of sourcesand methods to gather information, identifies and proposes potential solutions for addressing issues or problems and making decisions with consultation of SERM physician. N