TCS is hiring
Role : SERM Physician
Qualification : MBBS, MD
Roles & Responsibilities
Responsible for signal detection and evaluation activities for assigned products.
• 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.
• Assists in the production of Risk Management Plans (RMPs), Risk Tables for designated products, in consultation with
Senior personnel.
• 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.
• Acts as a member of a process improvement initiative team within the GCSP.
• Completes any post audit and inspection activities within the required timeline
• 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.
• Shows commitment to the task and effective time management to meet multiple deadlines successfully and with
attention to detail and quality. Able to priorities own workload with minimal guidance.
• Builds effective working relationships and responds to the needs of line functions in the matrix in relation to safety
issues.
• Supports safety governance or SRTs in the clinical development and post marketing settings by assisting in the
establishment and operation of cross-functional teams in any SERM to detect and address product safety issues and
ensures that risk-reduction strategies are implemented appropriately in clinical study protocols and or product
labelling.