Global Program Safety Lead(m/w/x)

Anforderungen

• Medical Degree or equivalent
• 3 years clinical experience postdoctoral
• Minimum 5 years experience in drug development
• Experience in clinical trial methodology and regulatory requirements
• Expertise in clinical safety assessments and regulatory submissions
• Experience with issue management
• Experience in leading cross-functional teams
• Fluent English (both spoken and written)
• Additional languages are an advantage
• Experience in Clinical Research and Clinical Trials
• Experience in Leadership and Medical Strategy

Aufgaben

• Provide expert safety input for clinical development programs
• Participate in the Global Program Team, Global Clinical Team, and Clinical Trial Team
• Lead the Safety Management Team
• Manage safety issues throughout the project lifecycle
• Own the safety strategy for projects and products
• Produce medical safety deliverables
• Develop and maintain safety information in the Core Data Sheet
• Address safety issues across all project and product indications
• Oversee signal detection and monitoring of safety information
• Evaluate and interpret safety data from relevant sources
• Prepare safety strategies for health authority responses
• Collaborate with project team members on safety inquiries
• Respond to regulatory authorities and healthcare professionals regarding safety issues
• Contribute to departmental and functional goals and objectives
• Engage in developing competencies within the Medical Safety Function

Berufserfahrung

Ausbildung

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