Senior Manager – Global Pharmacovigilance

About the role

Sun Pharma is seeking a Senior Manager to lead its Global Pharmacovigilance function. The role involves overseeing adverse event reporting, ensuring regulatory compliance, and supporting safety surveillance across multiple markets.

Key responsibilities

• Evaluate incoming communications (phone, fax, email, social media) for potential adverse event reports.
• Medically assess and process adverse event (AE) cases, determining seriousness and expedited reporting to FDA and Health Canada.
• Submit AE reports to the appropriate regulatory authorities within required timelines.
• Respond to daily queries and maintain literature case spreadsheets.
• Support internal audits, external inspections, and perform quarterly trending analyses.
• Prepare annual summary reports for Canadian‑marketed drug products.
• Reconcile product quality complaints and conduct monthly Health Canada AE searches.
• Provide ongoing AE case follow‑up and ensure receipt of events from marketing programs.

Required profile

• BDS, MDS, M.Pharm or equivalent healthcare/science qualification (RN, pharmacist acceptable).
• Minimum 5 years of experience in pharmacovigilance or drug safety.
• Strong understanding of FDA and Health Canada post‑marketing safety regulations.

Required skills

• Working knowledge of FDA and Health Canada guidelines.
• Proficiency with medical terminology and MedDRA coding.
• Experience using drug safety databases such as Wilke and Argus.
• Advanced MS Office skills (Word, Excel, PowerPoint).

What we offer

• Competitive benefits and opportunities for professional growth.
• Supportive, collaborative work environment.