Global Program Safety Lead (La Gran Via), Tena
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Tena, Colombia
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Publicado: ayer
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This is a director level role and can be based in Barcelona, Spain or London, UK (REQ- ) or Basel, Switzerland (REQ- ).
Location: Barcelona, SpainWorking pattern: HybridIf you are interested in one of the other locations please apply on the REQ number for that location.Key ResponsibilitiesSafety 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 Integral 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 RequirementsMedical Degree or equivalent is preferred; PhD, PharmD or equivalent graduate level healthcare professional degree required.3 years clinical experience postdoctoral.At least 5 years' experience in drug development within a major pharmaceutical company, includ
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Nombre de la empresaNovartis Pharma Schweiz
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Nombre de la vacanteGlobal Program Safety Lead (La Gran Via)
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