Beschreibung

You will drive patient safety by leading medical strategies and managing safety data throughout the product life cycle, ensuring clinical programs meet the highest regulatory standards.

Anforderungen

• •PhD, PharmD, or equivalent graduate degree
• •Three years clinical postdoctoral experience
• •Five years pharmaceutical drug development experience
• •Experience in clinical trial methodology
• •Expertise in clinical safety assessments
• •Experience with issue management
• •Experience leading cross-functional multicultural teams
• •Fluent English language skills
• •Additional languages as an advantage
• •Neuroscience experience

Aufgaben

• •Provide expert safety input for clinical development programs
• •Participate in global program and clinical trial teams
• •Lead the Safety Management Team
• •Manage safety issues throughout the product life cycle
• •Develop and own product safety strategies
• •Produce medical safety deliverables
• •Maintain safety information in Core Data Sheets
• •Address safety issues across all product indications
• •Oversee signal detection and safety data monitoring
• •Evaluate and manage safety information from all sources
• •Prepare safety strategies for health authority responses
• •Respond to regulatory and healthcare professional inquiries
• •Lead the development of departmental goals
• •Develop competencies across the medical safety function