Global Program Safety Lead

Office Location: London (The Westworks), United Kingdom

#LI-Hybrid Hybrid (12 days per month on-site if living within 50 miles of our London office)

#LI-Remote Remote (if living beyond 50 miles of our London office)

Alternative Location: Basel, Switzerland

#LI-Hybrid Hybrid (12 days per month on-site)

Major accountabilities:

• Safety Input and Team Participation: 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). Lead the Safety Management Team (SMT). Responsible for managing safety issues from the formation of the GPT through Life Cycle Management
• Safety Strategy Preparation: Own the projects/products safety strategy and lead the production of medical safety deliverables
• Core Global Labelling: Responsible for initial development and ongoing maintenance of safety information in Core Data Sheet, addressing safety issues in all project/product indications
• Signal Detection and Safety Management: Oversee overall signal detection, monitoring, evaluation, interpretation, and appropriate management of safety information, based on data from all relevant sources
• Regulatory and Professional Inquiries: Lead the preparation of the safety strategy for health authority responses and collaborate with other project team members. Respond to inquiries from regulatory authorities or healthcare professionals regarding safety issues
• Departmental and Functional Goals: Contribute to and often lead the development of departmental and functional/business unit goals and objectives. Proactively engages in the development of competencies across the Medical Safety Function

Role Requirements:

• Medical Degree or equivalent is preferred; PhD, PharmD or equivalent graduate level health care professional degree required 
• 3 years clinical experience postdoctoral
• Minimum 5 years’ experience in drug development in a major pharmaceutical company (of which 2 years in a global position), including 2 years in safety at an operational or medical position.
• Experience in clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing of publications  
• Expertise in preparing or contributing to preparation of clinical safety assessments and regulatory reports/submissions involving safety information
• Experience with (safety or others) issue management 
• Experience in leading cross-functional, multicultural teams  

Languages:

• Fluent English (both spoken and written) is mandatory

Additional desirable skills:

• Additional languages are an advantage
• Neuroscience experience

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: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards