Aggregate physician

Tata Consultancy Services · Mumbai, India

TCS is hiring for

Role: Aggregate Physician

Qualifications: MBBS, MD

Roles & Responsibilities

• Responsible for signal detection and evaluation activities for assigned products.
• Ensures that accurate and fit-for-purpose evaluation documents with clear 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.

Thanks & Regards

Babeeta Shahi

TCS – HR