Safety Physician

TCS is hiring for Safety Physician Role!!!

Location - Mumbai

Qualification: MBBS/ MD

Experience: Min 3 years experience in signal management, safety report authoring and reviewing, Benefit Risk management plan.

Job Responsibilities:

• Contributes to regulatory benefit-risk assessments and prepares the regional Risk Management Plans for designated products in partnership with the product scientist, provides clinical safety input into Clinical Development planning activities
• Provides input on cross-functional ad-hoc teams set up to address urgent and important safety issues.
• Runs routine signal detection process (including On-Line Signal Management Tool, literature review and, in partnership with product scientist, tools for individual case awareness) for all products in area or responsibility.
• Provides medical input to signal detection and subsequent evaluation for designated products in partnership with more senior physician Identifies and uses appropriate sources of information and database searches to retrieve relevant data for evaluation of signals.
• Authors periodic regulatory documents (PSURs, Annual Reports) according to the agreed process and timelines.
• Co-ordinates the compilation of large PSURs requiring a GCSP team approach and provides high-level summaries on major issues.
• Supports the Local Operating Companies by preparing license renewal documentation (e.g. PSUR addenda line listings, clinical overviews, summary bridging reports) as required for each market Provides medical input, review and sign-off of periodic reports (e.g. PSURs) and renewal

Interested candidates can apply for the role!!!

Best Regards,

Megha Dixit - TCS HR