Global Program Safety Lead

vor 10 Stunden

Basel, Schweiz Novartis Vollzeit

Job Description Summary Are you ready to make a significant impact in medical safety Novartis is seeking passionate individuals to join our innovative team. You will work with cutting‑edge technology, collaborate with experts, and drive excellence in patient safety. If you’re eager to advance your career and be part of a forward‑thinking company, we want you on our team Job Description Key Responsibilities Safety Input and Team Participation: Provide expert safety input to the clinical development program for assigned projects/products and actively participate in the Global Program Team (GPT), Global Clinical Team (GCT), and Clinical Trial Team (CTT). Lead the Safety Management Team (SMT). Responsible for managing safety issues from the formation of the GPT through Life Cycle Management. Safety Strategy Preparation: Own the projects/products safety strategy and lead the production of medical safety deliverables. Core Global Labelling: Responsible for initial development and ongoing maintenance of safety information in Core Data Sheet addressing safety issues in all project/product indications. Signal Detection and Safety Management: Oversee overall signal detection monitoring, evaluation, interpretation and appropriate management of safety information based on data from all relevant sources. Regulatory and Professional Inquiries: Lead the preparation of the safety strategy for health authority responses and collaborate with other project team members. Respond to inquiries from regulatory authorities or healthcare professionals regarding safety issues. Departmental and Functional Goals: Contribute to and often lead the development of departmental and functional/business unit goals and objectives. Proactively engage in the development of competencies across the Medical Safety Function. Role Requirements Medical degree or equivalent preferred; PhD, PharmD, or equivalent graduate‑level health‑care professional degree required. Minimum 5 years experience in drug development in a major pharmaceutical company (including 2 years in a global position) and 2 years in safety at an operational or medical position. Experience in clinical trial methodology, regulatory requirements, scientific methodology, statistics, and publication writing. Expertise in preparing or contributing to the preparation of clinical safety assessments and regulatory reports/submissions involving safety information. Experience with (safety or other) issue management. Experience leading cross‑functional multicultural teams. Languages Fluent English (both spoken and written) is mandatory. Additional Desirable Skills Additional languages are an advantage. Experience in dermatology/allergy or other immunology indications is preferred. 3 years clinical experience postdoctoral. Skills Desired Clinical Research, Clinical Trials, Functional Teams, Leadership, Medical Strategy, Process, Safety Management, Regulatory Compliance, Risk Management, Safety Science Required Experience: Exec Key Skills Project Management Methodology, Project/Program Management, Program Management, Management Experience, Microsoft PowerPoint, Project Management, Microsoft Project, Budgeting, DoD Experience, Leadership Experience, Supervising Experience, Contracts Employment Type: Full‑Time Experience: years Vacancy: 1 #J-18808-Ljbffr

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