Dirección
forma de trabajo The Senior Global Program Safety Lead 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. You will ensure optimal patient safety for assigned compounds, you are responsible for the integration, analysis, and interpretation of internal and external safety information from all sources through lifecycle management. You will provide expert safety input to the clinical development program for heavy weight/high profile projects/products. Provides guidance to assigned Medical Safety team members and builds an efficient team within the TA/DU.
Your key responsibilities, but not limited to;
• Manage an efficient and successful disease area within the TA/DU Medical Safety organization, which provides robust medical and science-driven contribution to Benefit-Risk evaluation throughout product lifecycle to enable Novartis to provide impactful medicines to patients worldwide.
• Enhance scientific and clinical experience of Medical Safety physicians / scientists through continuous training and coaching. Prepares safety objectives and evaluates and manages performance of the Medical Safety associates within the TA/DU.
• Lead the day-to-day safety activities and provides guidance to assigned Medical Safety team members and mentee(s), as well as to the direct reports. Prepares objectives and evaluates related performance for the assigned team members.
• Mentor junior CMO and Patient Safety personnel. Proactively engages in the development of competencies across the Medical Safety Function.
• Provide expert safety input to the clinical development program, in particular for heavy weight/high profile projects/products; is an active member of the Global Program Team (GPT), Global Clinical Team (GCT) and Clinical Trial Team (CTT).
• Provide guidance and support to assigned Medical Safety team members.
• Responsible for safety issue management from formation of GPT through Life Cycle Management.
• Develop and be responsible for key internal Novartis safety documents, reviews these documents regularly and updates as required (e.g., when significant new information received).
• Own the safety strategy and documents it appropriately (e.g. dSPP, SSPT); leads the production of the medical safety deliverables (e.g. DSUR, PSUR, RMP) for the assigned products.
• 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.
• Is responsible for documentation/tracking/record keeping of medical safety activities for the assigned compounds.
• Responsible for initial development and ongoing maintenance of safety information in Core Data Sheet (core global labelling), including addressing safety issues optimally in all project/product labelling indications.
