Beschreibung

In this role, you will play a crucial part in ensuring patient safety by leading safety strategies and managing safety information throughout the clinical development process. Your day-to-day responsibilities will involve collaborating with teams, overseeing safety evaluations, and responding to regulatory inquiries.

Anforderungen

• •Medical Degree or equivalent
• •3 years clinical experience postdoctoral
• •Minimum 5 years experience in drug development in a major pharmaceutical company
• •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 clinical safety assessments and regulatory reports/submissions
• •Experience with safety issue management
• •Experience in leading cross-functional, multicultural teams
• •Fluent English (both spoken and written)
• •Additional languages are an advantage

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