Associate Medical Director, Global Patient Safety

About the role

The Associate Medical Director, Global Drug Safety is accountable for executing safety and risk‑management activities for one or more assigned clinical development projects or marketed products, enabling the safe and effective use of Alexion’s products by patients and healthcare providers. This individual contributor role is responsible for safety activities for investigational and/or marketed products, including identification and evaluation of safety signals and risk management to drive risk/benefit decision‑making. The role reports to the Medical/Senior/Executive Director, Global Drug Safety.

Responsibilities

• Through data review and research, identify and present safety issues at Safety Management Team meetings for further review and analysis.
• Assist in preparation of safety data for DSMBs and other safety‑governance meetings.
• Represent Global Drug Safety on project/product teams or sub‑teams as a key cross‑functional member and subject‑matter expert.
• Detect, validate, and manage pre‑ and post‑approval safety signals through to resolution.
• Conduct medical review of Individual Case Safety Reports (ICSRs) and analysis of similar events (AOSE), assess quality within the ICSR process, identify process‑improvement opportunities, and drive changes.
• Evaluate aggregate safety data and contribute to core regulatory documents (e.g., Periodic Safety Update Reports, Drug Safety Update Reports, Risk Management Plans) and other routine or non‑routine safety and risk/benefit evaluations for internal or regulatory purposes.
• Identify, initiate, and manage safety updates to the Investigator’s Brochure, CCSI, local product information, Medication Guide, Patient Leaflet, and other labeling documentation as needed.
• Assist in regulatory responses to safety inquiries from regulatory agencies.
• Support initiatives outside of assigned projects when directed by the line function.

Requirements

• MD or equivalent degree.
• Minimum of 1 year experience in drug safety and risk management within the pharmaceutical, biotech, or CRO industry, or 3 years in a clinical care setting.
• Excellent independent judgment based on knowledge and expertise.
• Strong verbal and written communication skills, including the ability to recommend courses of action to management and senior leaders.
• Sound problem‑solving skills with the ability to develop innovative options and multiple solutions to complex problems.
• Proficiency with Microsoft Word, PowerPoint, and Excel.

Preferred qualifications

• Experience with rare, ultra‑rare, or orphan disease areas.
• Strong personal time‑management and project‑management skills.
• Knowledge of US and EU safety regulations, CIOMS, ICH, and GCP guidelines.
• Clinical development or research experience.
• Broad and deep knowledge of the principles, concepts, and theories of drug‑induced disease for relevant therapeutic/product areas.

Posted: 22 Sep 2026 | Closing Date: 28 Sep 2026