Senior Global Program Safety Team Lead
Location: Hyderabad, India
Job Type: Full Time
Job ID: REQ-10067167
About the Role
Novartis is seeking an accomplished Senior Global Program Safety Team Lead (Sr. GPSL-TL) to serve as a strategic leader within the Medical Safety organization. This role plays a critical part in strengthening patient safety, improving global safety risk management, and contributing to the success of high-value development programs across therapeutic areas.
The position requires deep expertise in safety science, the ability to anticipate and evaluate safety risks, and the capability to guide cross-functional teams on strategic risk-management decisions throughout the product lifecycle.
Key Responsibilities
Leadership & Strategic Oversight
Lead safety strategy and execution for assigned programs within the Medical Safety organization, ensuring robust scientific contribution to benefit-risk evaluations from early development through post-marketing.
Oversee day-to-day safety activities and provide mentorship, performance guidance, and leadership to assigned Medical Safety team members.
Collaborate closely with the Head of Patient Safety to support complex safety issues across multiple indications.
Program & Document Ownership
Serve as a core safety expert for global clinical programs and actively participate in key teams including GPT, GCT, and CTT.
Own the safety strategy for assigned compounds and ensure clear documentation in relevant planning tools (dSPP, SSPT).
Lead the preparation and delivery of high-quality medical safety documents, including DSURs, PSURs, and RMPs.
Review PSURs in partnership with the QPPV office and prepare content for MSRB presentations.
Signal Detection & Safety Evaluation
Lead signal detection, monitoring, interpretation, and risk evaluation using internal and external safety data sources.
Maintain safety information within the Core Data Sheet and ensure labeling reflects the most accurate risk profile.
Regulatory & Cross-Functional Collaboration
Prepare responses and strategic safety content for health authority queries, review boards, and inspections.
Attend Health Authority Meetings when required.
Present key safety topics to internal governance boards, including DevLT, TA LT, and Medical Safety LT.
Build and sustain strong cross-functional collaborations with Clinical Development, Medical Affairs, Regulatory Affairs, Biostatistics, Clinical Pharmacology, QA, BD&L, and external experts.
Required Education
Medical Degree (preferred), or PhD/PharmD with relevant advanced training.
Additional qualifications such as a postgraduate degree in Pharmaceutical Medicine or a Master of Public Health in Epidemiology are advantageous.
Required Experience
Minimum 7 years of progressive experience in drug development within a major pharmaceutical organization.
At least 5 years in a global safety or medical safety role, plus 5+ years of postdoctoral clinical experience.
Strong expertise in developing or contributing to clinical safety assessments, regulatory submissions, and NDA-level documentation.
Demonstrated leadership in managing global, multicultural, cross-functional teams.
Proven experience in issue management, safety strategy development, and lifecycle safety oversight.
Solid understanding of clinical trial methodology, regulatory requirements, safety science, statistics, and publication writing.
Extensive experience in medical writing and producing documents such as RMPs, PSURs, DSURs.
Strong interpersonal, coaching, and team-building skills.
Why Join Novartis
Novartis is built on a culture of innovation, collaboration, and global impact. Join a community of talented professionals working together to develop life-changing therapies. Learn more about our people-first approach at:
https://www.novartis.com/about/strategy/people-and-culture
Explore More Opportunities
If this role is not the right match, you can join the Novartis Talent Network:
https://talentnetwork.novartis.com/network
Benefits and Rewards
Learn about career development, personal well-being programs, and comprehensive rewards at:
https://www.novartis.com/careers/benefits-rewards
Additional Information
Division: Development
Business Unit: Development
Location: Hyderabad (Office)
Company: Novartis Healthcare Private Limited
Functional Area: Research & Development
Shift: No shift work
Accessibility and Inclusion
Novartis is committed to providing reasonable accommodation to applicants and employees with disabilities. For support during the recruitment process, email: diversityandincl.india@novartis.com with the job requisition number.
Novartis fosters an inclusive workplace and values diversity reflective of the communities and patients it serves.
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