Medical Director, Global Patient Safety

hace 1 semana


Barcelona, Barcelona, España Alexion Pharmaceuticals A tiempo completo

What You'll Be Doing:

The Medical Director, Global Patient Safety is responsible for overseeing safety and risk management activities for assigned clinical development projects or products to ensure safe and effective product usage by patients and healthcare providers. Utilizing clinical and pharmacovigilance expertise, the jobholder identifies and evaluates safety signals, contributes to risk/benefit assessments, interprets clinical trial data, and conducts risk assessments. This role reports to the Senior Medical Director, Risk Management Pharmacovigilance.

Your Responsibilities:

  • Lead evaluation and resolution of risk management for assigned products and projects
  • Identify potential safety issues for further review and analysis
  • Direct safety and risk/benefit activities for projects/products
  • Collaborate with internal and external teams on safety signal resolution
  • Ensure timely recording of risk management decisions
  • Conduct medical assessment of Individual Case Safety Reports
  • Evaluate aggregate safety data for reporting
  • Provide medical interpretation of safety and pharmacoepidemiological data
  • Update product information and labeling as needed
  • Evaluate issues related to pharmacovigilance operations
  • Provide medical input for search criteria development

Requirements:

  • MD Required
  • Minimum five years of safety and risk management experience in pharma
  • Knowledge of PV standards and processes
  • Deep understanding of drug-induced disease concepts
  • Strong communication and problem-solving skills
  • Ability to manage multiple complex tasks effectively

Preferred Qualifications:

  • 4+ years in clinical medicine
  • Experience in Rare, Ultra-Rare, or Orphan Disease Areas
  • Excellent time and project management abilities
  • Collaborative mindset for team success

Equal Employment Opportunity:

Alexion is an Equal Employment Opportunity and Affirmative Action employer. We value diversity and strive to create an inclusive work environment where everyone feels valued for their individuality. Decisions regarding employment are made without bias based on various factors. Alexion provides accommodations as needed. Contact us for accommodation requests. Alexion participates in E-Verify.



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