Instagram
youtube
Facebook

Senior Medical Director, Global Patient Safety

8+ years
Not Disclosed
10 April 24, 2025
Job Description
Job Type: Full Time Education: MD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Senior Medical Director, Global Patient Safety
Location: Barcelona, Catalonia, Spain
Job ID: R-210071
Date posted: 03/02/2025


About the Company:

Alexion, AstraZeneca Rare Disease is a global leader in the development of life-changing therapies for rare diseases. The company is committed to improving patient outcomes and driving innovation in the medical field. Alexion operates across multiple therapeutic areas, including hematology, nephrology, and other rare conditions, with an emphasis on patient safety and regulatory excellence.


Job Responsibilities:

  • Leadership and People Management:

    • Lead a team of Medical Directors and Safety Surveillance Scientists

    • Responsible for coaching, counseling, and developing direct reports

    • Represent Global Drug Safety in internal strategic/advisory/governance committees

  • Safety Surveillance and Risk Management:

    • Oversee global safety surveillance for assigned product portfolio throughout its lifecycle (pre and post-approval)

    • Lead decision-making based on complex risk/benefit evaluation and clinical trial data interpretation

    • Ensure timely detection and communication of new safety issues

    • Develop and implement risk minimization strategies

  • Collaboration and Representation:

    • Partner with internal leaders within Global Drug Safety and other Alexion functions

    • Represent Alexion at DSMB, Regulatory Authority meetings, or external conferences

  • Safety Signal Evaluation:

    • Lead teams in identifying and resolving safety signals

    • Ensure effective communication of risk management plans to internal and external stakeholders

  • Regulatory and Reporting:

    • Oversee the generation of aggregate reports, regulatory responses, and risk management documentation

    • Ensure compliance with international safety reporting requirements

  • Strategic Influence:

    • Work cross-functionally with Clinical, Medical Affairs, and Regulatory Affairs teams

    • Influence decision-making and drive evidence-based conclusions within the organization


Required Qualifications:

  • Education:

    • MD or equivalent degree

  • Experience:

    • 8+ years of experience in the pharmaceutical industry, specifically in safety and risk management

    • Extensive experience in signal detection, validation, and management

  • Skills and Abilities:

    • Proven leadership skills with a proactive, solution-oriented approach to safety signal detection and resolution

    • Excellent interpersonal, analytical, managerial, and organizational skills

    • Strong verbal and written communication, including influencing senior leaders across functions

    • Ability to navigate complex, matrixed environments and collaborate across teams

    • Sound judgment and problem-solving skills for complex safety-related issues


Preferred Qualifications:

  • Clinical Experience:

    • Clinical experience or post-training/residency in medicine

  • Specialized Knowledge:

    • Experience in Rare, Ultra-Rare, or Orphan Disease Areas

    • Expertise in pharmacovigilance and risk management at a global level

  • Presentation Skills:

    • Experience speaking at industry conferences with strong public speaking skills


Why Join Alexion:

  • Lead a dynamic team focused on patient safety in the rare disease space

  • Contribute to the development of innovative therapies that impact patient lives

  • Join an inclusive and diverse global team committed to excellence in all aspects of drug safety