18 Sep
|
Tata Consultancy Services
|
India
18 Sep
Tata Consultancy Services
India
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 advantage-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 (India)
🏢 Tata Consultancy Services
📍 India