Pharmacovigilance Manager - Drug Safety / Medical Affairs

Department : Drug Safety / Medical Affairs

Reports To : Head of Pharmacovigilance / Medical Director

Experience : 610 years in pharmacovigilance, with at least 23 years in a managerial role

Key Responsibilities :

Case Management & Reporting :

• Oversee end-to-end Individual Case Safety Report (ICSR) processing, including collection, triage, medical review, and submission to health authorities.
• Ensure timely and accurate reporting in line with global regulations (e.g., EMA, FDA, CDSCO).

Signal Detection & Risk Management :

Team Leadership :

Regulatory Compliance :

Cross-Functional Collaboration :

Systems & Process Improvement :

Key Skills :

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