| || The successful candidate will drive safety processes and capabilities within the assigned therapeutic area, be accountable for safety compliance for Integrated Safety activities within the therapeutic area, and develop the safety strategy for the therapeutic area.
Major Accountabilities include:
1 Accountable for the proper monitoring and handling of safety risks for all Novartis projects/products in the therapeutic area (TA). Maintains comprehensive safety documentation on the clinical experience with Novartis projects/products within the TA;
2 Accountable 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 prepared by the Brand Safety Leaders (BSLs) and Pharmacovigilance Leaders (PVLs) within the TA;
3 Establishes and maintains common global processes and guidelines for safety assessment, analysis, and compliance within the TA, including documented guidance for coding and the assessment of causality/expectedness for adverse event reports, and training of colleagues;
4 Ensures that medical safety signals from aggregate data are identified promptly and communicated 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;
5 Leads and/or coordinates as appropriate the preparation of medical stewardship data/information for Novartis boards, Integrated Medical Safety management, crisis management teams, and Health Authorities for TA safety issues;
6 Initiates 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 Operations and Data Management, other related departments and externally with expert panels and other external scientific contacts;
7 Represents Novartis medical safety at outside organizations like CIOMS, PhRMA, etc.
8 Identifies external consultants on safety issues, as appropriate, when internal resources may be insufficient or when third party advice is desirable.
| || Education:
Medical degree required. Specialty Board Certification desirable. Useful additional degrees: Post graduate degree in Pharmaceutical Medicine; Master of Public Health in Epidemiology (or equivalent)
English and reliable understanding in another major language (e.g. French, German, Spanish) desirable.
• 3 years clinical experience postdoctoral
• At least 7 years in drug development in a major pharmaceutical company (of which 5 years in a global position), including 5 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 other) issue management
• Experience in drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing of publications
• Management experience (2- 8 direct reports)