Global Program Safety Lead (CAR T-cell Therapy)

Updated: about 14 hours ago
Location: East Hanover, NEW JERSEY
Job Type: FullTime

769 million. That’s how many lives our products touched in 2020. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

Novartis has a mission to reimagine medicine by bringing curative cell & gene therapies to patients worldwide, and was one of the first pharmaceutical companies to pioneer CAR-T research and initiate global CAR-T trials. Novartis has a strong CAR-T pipeline and ongoing investment in manufacturing and supply chain process improvements. With active research underway to broaden the impact of cell and gene therapy in oncology, Novartis is going deeper in hematological malignancies, reaching patients with other cancer types and evaluating next-generation CAR-T cell therapies that focus on new targets and utilize new technologies.

Your responsibilities include, but are not limited to:
• Provide expert safety input to the clinical development program for assigned projects/products and be an active member of the Global Program Team (GPT), Global Clinical Team (GCT) and Clinical Trial Team (CTT)

• Responsible for safety issue management from formation of Global Program Team (GPT) through Life Cycle Management.

• Develops and is responsible for key internal Novartis safety documents: reviews these documents regularly and updates as required

• 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

• Responsible for documentation/tracking/record keeping of the assigned compounds medical safety activities

• Responsible 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

• Responsible for responses to inquiries from regulatory authorities or health care professionals on safety issues

• Leads the preparation of the safety strategy for health authority responses and strategy, in collaboration with other project team members

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