US-NJ, Therapeutic Area Safety Leader, Resp 227142BR-MZ
Therapeutic Area Safety Leader, Resp
Global Drug Development
CMO & PATIENT SAFETY GDD
East Hanover, NJ
Research & Development
Drives safety processes and capabilities within the assigned therapeutic area and is accountable for safety compliance for Integrated Safety activities within the therapeutic area. Develops the safety strategy for the therapeutic area.
1Accountable for the proper monitoring and handling of safety risks for all Novartis pro-jects/products in the therapeutic area (TA). Maintains comprehensive safety documentation on the clinical experience with Novartis projects/products within the TA 2Accountable for the delivery of high quality, timely and standardized safety deliverables across the TA. Provides content guidance and first-line approval for all safety documentation pre pared by the Brand Safety Leaders (BSLs) and Pharmacovigilance Leaders (PVLs) within the TA. 3Establishes and maintains common global processes and guidelines for safety assessment, analysis, and compliance within the TA, including documented guidance for coding and the as-sessment of causality/expectedness for adverse event reports, and training of colleagues. 4Ensures that medical safety signals from aggregate data are identified promptly and commu-nicated appropriately, including oversight (as appropriate) of use of signal detection tools and other in silico applications and/or of safety intelligence sources for potential product signals 5Leads and/or coordinates as appropriate the preparation of medical stewardship data/information for Novartis boards, Integrated Medical Safety management, crisis manage ment teams, and Health Authorities for TA safety issues. 6Initiates and maintains productive cross-functional medical safety collaborations internally with colleagues from Clinical Development and Medical Affairs, Drug Regulatory Affairs, Medical In-formation, Biostatistics & Statistical Reporting, Epidemiology, Global Pharmacovigilance Op-erations and Data Management, other related departments and externally with expert panels and other external scientific contacts. 7Represents Novartis medical safety at outside organizations like CIOMS, PhRMA, etc. 8Identifies external consultants on safety issues, as appropriate, when internal resources may be insufficient or when third party advice is desirable. 9 Responsible for in-licensing safety evaluation 10 Responsible for the safety profile/management of early/small projects/products within the TA; functions as BSL for these projects/products 11 Provides support as needed for licensing activities, regulatory authority inspections and for project/product recall activities. 12 Provides clinical safety input to the development of new/innovative clinical safety methodology 13 Prepares safety objectives and evaluates and manages performance of the TA BSLs and PVLs
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Medical degree required. Specialty Board Certification de sirable. Useful additional degrees: Post graduate degree in Pharmaceutical Medicine; Master of Public Health in Epide miology (or equivalent) English 3 years clinical experience postdoctoral At least 7 years in drug development in a major phar maceutical company (of which 5 years in a global posi tion), including 5 years in safety at an operational or medical position Experience in preparing or contributing to preparation of clinical safety assessments and regulatory re ports/submissions involving safety information Experience in leading cross-functional, multi-cultural teams Experience with safety (or other) issue management Experience in drug development, clinical trial methodol ogy, regulatory requirements, scientific methodology, statistics and writing of publications Management experience (2- 8 direct reports)
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