Biocon is seeking an experienced and detail-oriented Drug Safety Physician to join our Global Pharmacovigilance team. The ideal candidate will be responsible for evaluating drug safety data, conducting medical review of adverse event reports, and ensuring compliance with global regulatory safety requirements. This role plays a critical part in maintaining patient safety and supporting the benefit-risk assessment of Biocons products. Perform medical review and assessment of individual case safety reports (ICSRs) from clinical trials and post-marketing sources.

Provide medical expertise in signal detection, risk management, and safety data analysis.

Author and review aggregate safety reports (PSURs, PBRERs, DSURs) in accordance with global guidelines.

Contribute to the development and maintenance of Risk Management Plans (RMPs).

Collaborate with cross-functional teams including clinical, regulatory, and quality assurance.

Participate in safety signal evaluation and risk-benefit assessments.

Ensure all pharmacovigilance activities are compliant with global regulations (FDA, EMA, CDSCO). MBBS / MD (Pharmacology, Internal Medicine, or related specialty) is required.

26 years of experience in Pharmacovigilance, Drug Safety, or Clinical Research.

In-depth understanding of ICH, GVP, and global PV regulations.

Strong analytical, decision-making, and communication skills.

Experience with safety databases (e.g., Argus, ARISg) preferred.