Director of Safety Science

hace 3 semanas


Barcelona, Barcelona, España Alexion A tiempo completo
Job Title: Director, Safety Science

At Alexion, we are seeking a highly skilled and experienced Director, Safety Science to join our Global Patient Safety team. As a key member of our organization, you will play a leadership role in organizing and mentoring safety scientists to actively evaluate, manage, and strategize risk in collaboration with cross-functional team members within the global regulatory framework.

Key Responsibilities:
  • Lead risk management evaluation and resolution for assigned products and projects
  • Organize, train, and/or support junior safety scientists and fellows across multiple product portfolios and/or indications
  • Co-lead activities related to new drug applications and other regulatory filings
  • Represent global patient safety at regulatory inspections
  • Lead analysis to identify and address changes in global regulations, including updates to SOP and process documentation
  • Identify and address process gaps
  • Manage vendor relationships and training, including budgets
  • Oversee project distribution across therapeutic areas
  • Represent GPS in global program teams and associated cross-functional teams and/or projects
  • Provide guidance and educational training to GPS therapeutic teams
  • Participate in ongoing safety data review and analysis for products in designated therapeutic areas
  • Responsible for Signal Review Meeting and Signal Management Team activities in collaboration with GPS Medical Directors
Requirements:
  • Advanced degree in a biologic/medical/clinical/nursing field: Pharmacist/PharmD, Nurse Practitioner or PhD with at least 7 years experience in drug safety and risk management within the pharmaceutical, biotech, or CRO industry
  • Knowledge and understanding of US and EU safety regulations pre- and post-marketing
  • Experience with Risk Management and Minimization programs
  • Experience preparing post-marketing safety regulatory documents, including PSURs, PBRERs, and Risk Management Plans
  • Experience with clinical development, including risk/benefit analysis and safety assessment
  • Strong clinical, analytical, problem-solving, and scientific writing and communication skills

This role is generally conducted in an office environment.



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