Global Program Safety Lead(m/w/x)

Beschreibung

As a Global Program Safety Lead, you will play a crucial role in ensuring patient safety by providing expert input on clinical development programs, managing safety strategies, and collaborating with various teams to effectively address safety issues.

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