Job Description Summary
Responsible for the drug surveillance program including the necessary follow-up, risk assessment, and relatedness to product on adverse reaction reports, oversight of safety in clinical trials and post marketing programs. Participates in the resolution of any legal liability and complying with governmental regulations. Provides and contributes trending and safety signal detection and risk management assessment for the products’ life cycle. Provides safety support to the clinical development teams.

Job Description
Working Model: Hybrid (12 days/month in office)
LI-Hybrid

Key accountabilities:
- Monitor clinical safety data, including literature, case reports, and signal detection activities
- Drive the application of AI-enabled solutions to simplify and enhance pharmacovigilance processes, leveraging knowledge of AI agents and their use in medical safety.
- Conduct medical assessment of individual adverse event cases and ensure accurate evaluation
- Identify, evaluate, and monitor safety signals using single-case and aggregate data




- Contribute to responses for regulatory authorities and healthcare skilled safety inquiries
- Support preparation of core safety documents, including clinical overviews and summary reports
- Provide medical input to aggregate safety reports and regulatory submissions
- Collaborate cross-functionally to integrate safety insights across global development teams
- Guide adverse event coding, causality assessment, and interpretation of clinical safety data

Essential Requirements:
- Degree in Pharmacy, Nursing, Pharmacology, Life Sciences, or a medical degree (medical degree required for roles involving medical review of individual case safety reports)
- Fluency in written and spoken English
- At least 3 years’ experience in drug development within a pharmaceutical company (including 2 years in patient safety at an operational or medical position is preferred)
- Experience in clinical trial methodology, regulato

📌 Medical Safety Lead (Hyderabad)
🏢 Novartis
📍 Hyderabad