Senior Global Program Safety Team Lead - Immunology
Job ID REQ-10055040
Summary
Are you ready to lead with excellence and make a significant impact on our company's safety surveillance strategy? We are looking for a dynamic and strong people manager to design and develop our safety surveillance strategy for product approval.
Join us and be the driving force behind our commitment to safety and excellence!
About the Role
Major accountabilities:
1. Manage an efficient and successful disease area within the Therapeutic Area (TA)/Development Unit (DU) Medical Safety organization, providing robust medical and science-driven contributions to Benefit-Risk evaluation throughout the product lifecycle to enable Novartis to deliver impactful medicines to patients worldwide.
2. Enhance the scientific and clinical experience of Medical Safety physicians/scientists through continuous training and coaching. Prepare safety objectives, evaluate, and manage the performance of Medical Safety associates within the TA/DU. Identify talents and high-potential associates, and support their career development.
3. Provide expert safety input to the clinical development program for assigned projects/products and actively participate in the Global Program Team (GPT), Global Clinical Team (GCT), and Clinical Trial Team (CTT). Responsible for safety issue management from formation of GPT through Lifecycle Management.
4. Oversee signal detection, monitoring, evaluation, interpretation, and appropriate management of safety information from all relevant sources, including post-marketing data.
5. Ensure proper documentation, tracking, and record-keeping of medical safety activities related to assigned compounds.
6. Respond to inquiries from regulatory authorities and healthcare professionals regarding safety issues.
7. Lead the development of safety strategies for health authority responses in collaboration with project team members. Contribute to departmental and business unit goals and objectives.
8. Qualifications include a Medical Degree or equivalent (preferred), PhD, PharmD, or related graduate health care degree. Specialty Board certification is desirable, along with postgraduate degrees such as Pharmaceutical Medicine or Public Health in Epidemiology.
9. Minimum of 5 years of clinical experience postdoctoral and at least 7 years of progressive experience in drug development, including 5 years in a global safety position.
10. Expertise in preparing safety assessments and regulatory submissions, strong leadership skills, and experience with medical writing and issue management are required.
Languages: Additional languages are an advantage.
Why Novartis: Helping people with disease and their families takes more than innovative science. It requires a community of passionate people. Collaborate, support, and inspire each other to achieve breakthroughs that change patients’ lives. Learn more about our culture.
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Novartis is committed to building an inclusive and diverse work environment that reflects the communities we serve.
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