Global Program Safety Lead Job in New Jersey (NJ), Research and Development Career, Full Time Jobs in Novartis Pharmaceuticals
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Global Program Safety Lead job in East Hanover

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Novartis Pharmaceuticals jobs
New Jersey (NJ), East Hanover
Job Code:  247994BR
Employer:  Novartis Pharmaceuticals
Category:  Research and Development
Job Type:  Full Time

Location
Country:  United States
State:  New Jersey (NJ)
City:  East Hanover
Map: 
09/05/2018

Description
Successfully 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. Ensures optimal patient safety for assigned compounds, is responsible for the integration, analysis, and interpretation of internal and external safety information from all sources through lifecycle management.
Provides 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). 2. Is responsible for safety issue management from formation of Global Program Team (GPT) through Life Cycle Management. 3. Develops and is responsible for key internal Novartis safety documents: reviews these documents regularly and updates as required (e.g. when significant new information received). Ensures that these, and all other project-related safety documents, are consistent in safety messages. 4. Owns the safety strategy and document it in the corresponding documents (e.g. dSPP, SSPT) and leads the production of the medical safety deliverables (e.g. DSUR, PSUR, RMP) for the assigned products. 5. Is 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. 6. Responsible for documentation/tracking/record keeping of the assigned compounds medical safety activities. 7. Is responsible 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. 8. Is 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. GPSL_Version 5 Prepares safety data for health authority review boards (together with the clinical and biostatistical functions). Attends Health Authority Meetings in person, as required. 9. Is responsible for responses to legal queries and Country Organization (CO) requests involving safety issues. Provides integrated safety input into all regulatory documents required during active development. 10. Ensures safety information is communicated/escalated to HPS/MPH, HMS HYD and/or EU Qualified Person in a timely fashion. 11. Facilitates involvement of externalMedical Degree or equivalent (preferred), PhD, PharmD or equivalent graduate level health care professional degree required. Specialty Board certification desirable. Useful additional degrees: Post gr English 3 years clinical experience postdoctoral. At least 5 years are in drug development in a major pharmaceutical company (of which 2 years in a global position), including 2 years in safety at an operational or medical position . Experience in preparing or contributing to preparation of clinical safety assessments and regulatory reports/ submissions involving safety information. Experience in leading cross-functional, multi-cultural teams. Experience with (safety or others) issue management. Experience in drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing of publications
ref: (247994BR)
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