Senior Global Program Safety Team Lead
Location: Hyderabad, India
Job Type: Full-Time | Regular | On-Site
Business Unit: Development | Research & Development
About Novartis
At Novartis, we are dedicated to improving patients’ lives worldwide by combining cutting-edge science with passionate teams. Our mission is to deliver impactful medicines through innovative research, global clinical development, and robust safety management. We value collaboration, inclusion, and leadership that drives meaningful change in patient care.
Join Novartis to work in a dynamic, cross-functional environment where your expertise will directly impact patient safety and global development programs.
Position Overview
The Senior Global Program Safety Team Lead (Sr. GPSL-TL) is a strategic leader within the Medical Safety organization. This role is responsible for managing global safety teams, predicting and mitigating safety risks, and providing scientific guidance across assigned compounds and indications.
The Sr. GPSL-TL ensures optimal patient safety by integrating, analyzing, and interpreting internal and external safety data across the product lifecycle. This position requires strong collaboration, matrix leadership, and the ability to manage complex safety issues in partnership with the Head of Patient Safety and cross-functional teams.
Key Responsibilities
Lead and manage a disease-area safety team within the Medical Safety organization, including mentoring and evaluating team members.
Oversee daily safety operations, providing expert guidance on risk management and strategic safety decisions.
Act as a key contributor to the Global Program Team (GPT), Global Clinical Team (GCT), and Clinical Trial Team (CTT).
Review and interpret safety data from multiple sources, including post-marketing, clinical trials, and external literature.
Develop and implement safety strategies (e.g., dSPP, SSPT) and prepare regulatory deliverables such as DSURs, PSURs, and RMPs.
Lead responses to health authority inquiries and prepare safety data for regulatory review boards. Attend health authority meetings as required.
Provide input to internal Novartis boards and senior management, contributing to Benefit-Risk evaluation for assigned products.
Build and maintain cross-functional collaborations with Clinical Development, Medical Affairs, Regulatory Affairs, Biostatistics, QA, and external expert panels.
Ensure continuous integration and alignment of safety processes across global teams and multiple indications.
Required Qualifications
Education:
Medical degree preferred (MD, MBBS), or equivalent graduate-level healthcare degree (PharmD, PhD)
Specialty board certification desirable
Additional qualifications such as a Master’s in Pharmaceutical Medicine or MPH/Epidemiology are advantageous
Experience:
Minimum 7 years of progressive experience in drug development within a major pharmaceutical company, including:
At least 5 years in a global safety leadership role
5+ years postdoctoral clinical experience
Expertise in clinical safety assessments, regulatory reports, and NDA submissions
Strong experience in cross-functional, multi-cultural team leadership
Proven ability in medical writing and preparation of high-quality safety documents (RMPs, PSURs)
Demonstrated understanding of drug development, clinical trial methodology, regulatory requirements, and statistics
Skills & Competencies:
Strong leadership, coaching, and team development skills
Excellent collaboration and stakeholder management capabilities
In-depth knowledge of safety signal detection, risk management, and global regulatory requirements
Ability to influence decisions and provide strategic input at the organizational level
Why Join Novartis
At Novartis, your work will directly impact patients’ lives while providing opportunities for global exposure and professional growth. We are committed to an inclusive, diverse, and accessible work environment, where innovation, collaboration, and integrity are at the core of everything we do.
Benefits & Rewards: Competitive compensation, career development opportunities, and a supportive work culture designed to help you thrive both professionally and personally.
Application & Accessibility
Novartis provides reasonable accommodations for applicants with disabilities. To request an accommodation, please email diversityandincl.india@novartis.com with the requisition number REQ-10067167 and your request details.
Novartis is an equal opportunity employer, committed to building inclusive teams that reflect the diversity of the patients and communities we serve.
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