Joining the innovative Cardio Renal Metabolism team as Global Program Safety Lead. Collaborating with expertise while managing safety strategies for clinical development.
Responsibilities
Provide expert safety input to the clinical development program for assigned projects/products
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
Own the projects/products safety strategy and lead the production of medical safety deliverables
Responsible for initial development and ongoing maintenance of safety information in Core Data Sheet, addressing safety issues in all project/product indications
Oversee overall signal detection, monitoring, evaluation, interpretation, and appropriate management of safety information
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
Contribute to and often lead the development of departmental and functional/business unit goals and objectives
Proactively engages in the development of competencies across the Medical Safety Function
Requirements
Medical Degree or equivalent is preferred; PhD, PharmD or equivalent graduate level health care professional degree required
3 years clinical experience postdoctoral
Minimum 5 years experience 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 clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing of publications
Expertise in preparing or contributing to preparation of clinical safety assessments and regulatory reports/submissions involving safety information
Experience with (safety or others) issue management
Experience in leading cross-functional, multicultural teams
Languages: Fluent English (both spoken and written) is mandatory.
Additional desirable skills: Additional languages are an advantage. CRM experience
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