Job DescriptionTCS is hiring
NRole: SERM Physician
NQualification : MBBS, MD
NRoles & Responsibilities
NResponsible for signal detection and evaluation activities for assigned products.
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- Ensures that accurate and fit-for-purpose evaluation documents with explicit conclusions are provided in response to
Ninternal or regulatory authority requests for safety data.
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- Assists in the production of Risk Management Plans (RMPs), Risk Tables for designated products, in consultation with
NSenior personnel.
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- 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.
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- 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
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- 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.
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- 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.
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- Builds effective working relationships and responds to the needs of line functions in the matrix in relation to safety
Nissues.
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- 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.
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