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Director, Safety Science Leader

hace 2 meses

Barcelona, Barcelona, España Alexion A tiempo completo

**Job Summary**

The Director, Safety Science Leader will play a leadership role within Global Patient Safety at Alexion, organizing and mentoring safety scientists to actively evaluate, manage and strategize risk in collaboration with the GDS Medical Directors and cross-functional team members within the global regulatory framework.

**Key Responsibilities**

  • Lead risk management evaluation and resolution for assigned products and projects.
  • Accountability for the following:
    • Proven skill set for strategic leadership in a cross-functional matrix.
    • 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, including MHRA, FDA, EMA, etc.
    • Lead analysis to identify and address changes in global regulations, including updates to SOP and process documentation.
    • Leading activities to identify and address process gaps.
    • Responsible for vendor management and training, including budgets.
    • Responsible for overall project distribution across therapeutic area.
    • As needed, represent GPS in global program teams and associated cross-functional teams and/or projects.
    • Proactively 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.
    • Responsible for project managing and authoring of safety documents, including PSUR, PBER, PADER, RMP, REMS, CSRs, and ad hoc requests in collaboration with safety physicians.
    • Responsible for authoring safety section in collaboration with team members on regulatory responses, IBs/CCDS, protocol, ICF review, Data Monitoring Committees reports and requests, and other documents, and provide the necessary quality control to ensure alignment with core safety position.
    • Manage portfolio of products/projects related to risk management; assists Safety Physicians in the development of risk management strategy and activities for assigned products.

**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.

**Work Environment**

The duties of this role are generally conducted in an office environment.