Aggregate Physician

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 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.

• 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.

Thanks & Regards

Babeeta Shahi

TCS – HR