Global Program Safety Lead, Immunology, Hepatology & Dermatology

Nov 10, 2021

Job Description

125 million! That is the estimated number of people worldwide with psoriasis. NASH affects 2-6% of the global population, Atopic Dermatitis is prevalent in 15-20% of children and 1-3% of adults worldwide, and the global age-standardized prevalence of knee osteoarthritis is ~4%.

These and other diseases in the fields of Dermatology, Rheumatology, Hepatology and Transplantation still have significant unmet medical needs, and Novartis IHD franchise is focused on transforming the lives of patients living with these conditions.

As a Global Program Safety Lead (GPSL) within the Immunology, Hepatology & Dermatology (IHD) franchise, you will provide scientific and strategic leadership to optimize benefit-risk for compounds in these therapeutic areas. You will ensure optimal patient safety for assigned compound(s) and will be responsible for the integration, analysis and interpretation of internal and external safety information from all sources through lifecycle management.

Your duties will include, but are not limited to:
• Providing expert safety input to the clinical development program for assigned projects/products, participating as an active member of the Global Program Team (GPT), Global Clinical Team (GCT) and Clinical Trial Team (CTT).
• Developing, and overall responsibility for key internal Novartis safety documents: reviewing these documents regularly and updating as required (e.g. when significant new information is received). Ensuring that these, and all other project-related safety documents (e.g. DSUR, PSUR, RMP), are consistent in safety messages.
• Responsibility 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, constituting and running the Safety Management Team (SMT); ensuring that this team 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 in an appropriate and timely manner.
• Initial development and ongoing maintenance of safety information in Core Data Sheet (core global labeling), including addressing safety issues optimally in all project/product labeling indications.
• Responsibility for responses to inquiries from regulatory authorities or health care professionals on safety issues. Leading the preparation of the safety strategy for health authority submissions, responses and strategy, in collaboration with other project team members.

Expectations on strategic input, leadership, and mentorship of other members of the safety team will be based on the successful candidate’s level of expertise.

Diversity & Inclusion / EEO

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

Minimum Requirements

What you will bring to the role:
• Medical Degree or equivalent (preferred), PhD, PharmD or equivalent graduate level health care professional degree is required.
• Fluency in spoken and written English
• +3 years clinical experience postdoctoral and +5 years’ experience of drug development in a major pharmaceutical company (of which 2 years should be in a global position)
• +2 years in safety at an operational or medical position is preferable, with experience in scientific analysis, clinical safety assessments and regulatory discussions on safety and risk management
• Experience in leading cross-functional, multi-cultural teams and of (safety or others) issue management
• Experience in drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing of publications

•Specialty Board certification.

Why consider Novartis?
769 million lives were touched by Novartis medicines in 2020, 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 do here at Novartis!

Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here:
Global Drug Development
Research & Development
Full Time
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Global Program Safety Lead, Immunology, Hepatology & Dermatology

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