11 Oct
|
Tata Consultancy Services
|
Mumbai
11 Oct
Tata Consultancy Services
Mumbai
- Author, review, and approve aggregate safety reports including:
- PSUR/PBRER
- DSUR
- PADER
- ACO Reports
- Risk Management Plans (RMPs)
- Perform medical evaluation and interpretation of safety data.
- Conduct benefit-risk assessments for assigned products.
- Review signal detection outputs and support signal management activities.
- Collaborate with cross-functional teams including Clinical Development, Regulatory Affairs, Epidemiology, and Medical Affairs.
- Ensure compliance with global regulatory requirements including ICH, FDA, EMA, and local health authorities.
- Provide medical input for safety governance meetings.
- Support health authority responses and inspections/audits.
- Review literature and emerging safety information relevant to assigned products.
📌 Aggregate Physician (Mumbai)
🏢 Tata Consultancy Services
📍 Mumbai