Sr. Global Program Safety Team Lead

Summary

Designs & develops safety surveillance strategy for products and approval. Responsible for the company’s drug surveillance program including the necessary follow-up, risk assessment, and relatedness to product on adverse reaction reports, oversight of safety in clinical trials and post marketing programs. Participates in the resolution of any legal liability and complying with governmental regulations. Provides and contributes trending and safety signal detection and risk management assessment for the products’ life cycle. Provides safety support to the clinical development teams.

About the Role

The Senior Global Program Safety Team Lead s uccessfully serves as scientific safety leader of the Medical Safety organization to improve patients’ lives and impact on overall Novartis results through robust safety evaluation expertise and medical innovation. You will ensure optimal patient safety for assigned compounds, you are responsible for the integration, analysis, and interpretation of internal and external safety information from all sources through lifecycle management. You will provide expert safety input to the clinical development program for heavy weight/high profile projects/products. Provides guidance to assigned Medical Safety team members and builds an efficient team within the TA/DU.

Your key responsibilities, but not limited to;

• Manage an efficient and successful disease area within the TA/DU Medical Safety organization, which provides robust medical and science-driven contribution to Benefit-Risk evaluation throughout product lifecycle to enable Novartis to provide impactful medicines to patients worldwide.
• Enhance scientific and clinical experience of Medical Safety physicians / scientists through continuous training and coaching. Prepares safety objectives and evaluates and manages performance of the Medical Safety associates within the TA/DU.
• Lead the day-to-day safety activities and provides guidance to assigned Medical Safety team members and mentee(s), as well as to the direct reports. Prepares objectives and evaluates related performance for the assigned team members.
• Mentor junior CMO and Patient Safety personnel. Proactively engages in the development of competencies across the Medical Safety Function.
• Provide expert safety input to the clinical development program, in particular for heavy weight/high profile projects/products; is an active member of the Global Program Team (GPT), Global Clinical Team (GCT) and Clinical Trial Team (CTT).
• Provide guidance and support to assigned Medical Safety team members.
• Responsible for safety issue management from formation of GPT through Life Cycle Management.
• Develop and be responsible for key internal Novartis safety documents, reviews these documents regularly and updates as required (e.g., when significant new information received).
• Own the safety strategy and documents it appropriately (e.g. dSPP, SSPT); leads the production of the medical safety deliverables (e.g. DSUR, PSUR, RMP) for the assigned products.
• Responsible for overall signal detection, monitoring, evaluation, interpretation and appropriate management of safety information, based on information from all relevant line functions, post-marketing data, and other sources. To this end, constitutes and runs the Safety Management Team (SMT). Ensures that this team appropriately and timely reviews all medical safety data from various sources (e.g. pre-clinical, clinical trial data post-marketing, literature) throughout the development and post-approval process.
• Is responsible for documentation/tracking/record keeping of medical safety activities for the assigned compounds.
• Responsible for initial development and ongoing maintenance of safety information in Core Data Sheet (core global labelling), including addressing safety issues optimally in all project/product labelling indications.

Educational Background:

Medical Degree or equivalent (preferred), PhD, PharmD or equivalent graduate level health care professional degree required. Specialty Board certification desirable.

Useful additional degrees: Post graduate degree in Pharmaceutical Medicine; Master of Public Health in Epidemiology (or equivalent).

Languages:

Fluent in spoken and written English. Understanding in another major language (e.g. French, German, Spanish) desirable.

Why Novartis?

766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity, and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could achieve here at Novartis!

Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.

Accessibility and accommodation

Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

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?

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