Medical Director, Global Patient Safety

Responsibilities

• Execute safety and risk management activities for clinical development projects and marketed products to ensure safe and effective use.
• Lead risk management evaluation and resolution, including the identification and evaluation of safety signals.
• Provide overall scientific and clinical safety content for assigned assets or indications.
• Chair or direct Safety Management Teams to ensure a risk/benefit driven agenda from inception to closure.
• Represent the Global Patient Safety team at internal strategic committees and external regulatory authority meetings.
• Evaluate aggregate safety data and contribute to core regulatory documents such as PBRERs, RMPs, and other safety evaluations.
• Manage necessary updates to Investigator Brochures (IB), local product information, and labeling documentation.
• Deliver robust analyses of clinical safety data to drive interpretations and develop novel proposals.

Requirements

• MD or equivalent degree, or a degree in life sciences, pharmacy, or nursing.
• Demonstrated experience in Patient Safety and/or Clinical/Drug Development.
• Strong problem-solving skills with the ability to develop innovative solutions to complex problems.
• Proven ability to manage multiple overlapping complex tasks and projects under tight timelines.
• Knowledge of US and EU safety regulations for both pre- and post-marketing phases.

Preferred Qualifications

• 2-3 years of relevant safety and risk management experience within the pharmaceutical, biotech, or CRO industry.
• Experience working within Rare, Ultra-Rare, or Orphan Disease areas.
• Strong verbal and written communication skills with the ability to influence senior leadership.
• Excellent independent judgment and strong project management skills.
• Proficiency in Microsoft Word, PowerPoint, and Excel.

About the Company

Alexion, a part of AstraZeneca, is a leading biopharmaceutical company focused on delivering life-changing therapies for people with rare diseases. We are committed to fostering a culture of belonging where every individual can thrive through their unique contributions.