Global Medical Director, Patient Safety & Risk

Alexion; Barcelona; Vor Ort; EUR 140.000 - 200.000; Vollzeit

Zusammenfassung

Alexion seeks a Medical Director, Global Patient Safety to lead safety risk management for assigned products and development programs, ensuring safe and effective use for patients and clinicians. You will guide safety content, contribute to regulatory documents, and represent GPS in governance forums, delivering analyses to support risk/benefit decisions.

Requires an MD or equivalent in life sciences with strong Patient Safety and Drug Development experience.

Qualifikationen

• MD or equivalent degree in life sciences/pharmacy/nursing.
• Experience in Patient Safety and/or Clinical/Drug Development.
• Ability to manage multiple complex tasks and timelines.

Aufgaben

• Lead risk management evaluation and resolution for products and projects.
• Own safety content for assigned assets and indications.
• Deliver Safety & Strategy Management Team and Safety Surveillance Team outcomes.
• Define safety content aligned to GPT strategy and safety messaging.
• Contribute to study design and safety-related documentation.
• Chair or direct Safety Management Team with risk/benefit focus.
• Represent GPS in internal committees and external meetings.
• Detect, validate and manage safety signals pre- and post-approval.
• Evaluate safety data for regulatory documents and labeling updates.
• Provide safety analyses to support regulatory decisions.
• Serve as safety knowledge source for Product Team.

Kenntnisse

Problem solving

Multi-tasking

Verbal communication

Written communication

Microsoft Word

Microsoft PowerPoint

Microsoft Excel

Ausbildung

MD or life sciences/pharmacy/nursing degree

Tools

Microsoft Word

PowerPoint

Excel

Jobbeschreibung

Alexion seeks a Medical Director, Global Patient Safety to lead safety risk management for assigned products and development programs, ensuring safe and effective use for patients and clinicians. You will guide safety content, contribute to regulatory documents, and represent GPS in governance forums, delivering analyses to support risk/benefit decisions.

Requires an MD or equivalent in life sciences with strong Patient Safety and Drug Development experience.