Global Program Safety Lead

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 engages in the development of competencies across the Medical Safety Function

Role 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 languages are an advantage

Skills Desired

Clinical Research, Clinical Trials, Functional Teams, Leadership, Medical Strategy, Process Safety Management, Regulatory Compliance, Risk Management, Safety Science

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