Job DescriptionTCS is hiring NRole: SERM Physician NQualification: MBBS, MD 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
- 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 Naddressing issues or problems and making decisions with consultation of SERM physician. N
- Shows commitment to thetask 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 ShahinTCS– HR