Global Program Safety Lead

Job Description

Your responsibilities include, but are not limited to: 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). Is 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 (e.g. when significant new information received). Ensures that these, and all other project-related safety documents, are consistent in safety messages. 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. 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. Keeps working instructions / SOPs / GOPs for the area of responsibility up to date with internal (e.g., QMs) and external (e.g., GVP modules) requirements, provides input to such procedural documents of other functions, and ensures implementation of such procedural documents in the area of responsibility. Provides support as needed for licensing activities, regulatory authority inspections and for project /product recall activities. 18. Leads the day-to-day safety activities and provides guidance to junior personnel. Proactively engages in the development of competencies across the Medical Safety.Minimum requirements Medical Degree or equivalent (preferred), PhD, PharmD or equivalent graduate level health care professional degree required. Specialty Board certification desirable. Fluent in spoken and written English. Understanding in another major language (e.g. French, German, Spanish) desirable 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 re- ports/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 publicationsWhy consider Novartis 750 million. That s how many lives our products touch. 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 We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you re given opportunities to explore the power of digital and data. Where you re empowered to risk failure by taking smart risks, and where you re surrounded by people who share your determination to tackle the world s toughest medical challenges. We are Novartis. Join us and help us reimagine medicine. Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons.,

Keyskills :
lifecycle graduatelevel issuemanagement drugdevelopment safetymanagement equalopportunities clinicaldevelopment regulatoryrequirements clinicaltrial signaldetection tatementsofworksow