Medical Safety Lead
About the Role
Job Title: Medical Safety Lead – Global Health
Location: Hyderabad, India
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 professional 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, regulatory requirements, scientific methodology, and statistical principles, including authorship of scientific publications
- Strong ability to analyse, interpret, and clearly communicate clinical safety data to diverse stakeholders
- Experience in safety and cross-functional issue management (e.g., regulatory inquiries, compliance issues, labelling updates, and risk escalations)
- Proven experience contributing to safety reports and regulatory documentation
Desirable Skills
- Experience of using professional AI tools and agents for process improvement is strongly preferred
- Experience managing clinical safety issues
If you are passionate about patient safety and want to make a meaningful impact at scale, we encourage you to apply and join us in reimagining medicine together!
Role Requirements
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
Read our handbook (PDF 30 MB)
