125 million! 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 high unmet medical needs. Novartis IHD franchise is focused on, and well positioned to, transform the lives of these patients
As a Global Program Safety Lead, you will provide scientific and strategic leadership to optimize benefit-risk for compounds in these therapeutic areas. You will help support 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.
As a Global Program Safety Lead within the 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 and being an active member of the Global Program Team (GPT), Global Clinical Team (GCT) and Clinical Trial Team (CTT).
• Developing and 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.
• Responsibility for 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.
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