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
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Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
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Kyiv |Lima Region :
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Niš |Bohemia :
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