Global Program Safety Lead (Oncology)

Updated: about 1 month ago
Location: East Hanover, NEW JERSEY
Job Type: FullTime

90+ projects in clinical development were this safety position would play a key leadership role in supporting patient safety for breakthrough innovative immuno-oncology medicines.

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 Oncology 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 effectively 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.


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