Senior Medical Director, Global Drug Safety Expert

4 weeks ago

Boston, Massachusetts, United States Alexion Full time

Job Summary:

The Senior Medical Director, Global Drug Safety Expert will provide strategic and operational oversight of Alexion's Safety Surveillance and Risk Management activities for assigned therapeutic areas. This includes defining the Safety Surveillance and Risk Management strategy and ensuring its execution through leadership of a team of Medical Directors and Safety Scientists.

Key Responsibilities:

  • Lead a team of Medical Directors and Safety Scientists in identifying, evaluating, and facilitating resolution of safety signals, including effective communication of risk management plans.
  • Provide medical and pharmacovigilance expertise to oversee and lead decision-making based on complex risk/benefit evaluation, pharmacoepidemiological or clinical trial data interpretation, risk assessment, and risk mitigation.
  • Partner with internal leaders within Global Patient Safety and other Alexion functions and affiliates to deliver integrated pharmacovigilance and risk management support to the Alexion business.
  • Lead Product Safety Management Teams with Medical Directors to support key decision-making, drive evidence-based conclusions, and develop pivotal next steps.
  • Oversee work carried out on products and/or issues under highest scrutiny from a patient safety or regulatory perspective.
  • Ensure ongoing and adequate safety surveillance and timely detection and communication of new safety issues by the team.
  • Ensure timely and adequate generation of aggregate reports, regulatory responses, and risk management documentation by the team, according to international requirements and internal standards.

Requirements:

  • MD or equivalent degree or a life sciences/pharmacy/nursing degree, with demonstrated Patient Safety and/or Clinical/Drug Development experience.
  • Sound problem-solving skills, including the ability to make decisions by developing innovative options and/or multiple solutions to highly complex problems.
  • The ability to manage multiple overlapping complex tasks to conclusion, sometimes to tight timelines, for several projects and sub-projects, including oversight of others working on those projects.
  • Knowledge and understanding of GPS deliverables, standards, and processes.
  • Knowledge and understanding of US and EU safety regulations pre- and post-marketing.

Preferred Qualifications:

  • 5-7 years of relevant safety and risk management experience in the pharmaceutical, biotech, or CRO industry.
  • Rare, Ultra-Rare, or Orphan Disease Area experience.
  • Strong verbal and written communication skills, including making recommended courses of action to management and/or senior leaders that impact the discipline, department, or line, and influences their decisions.
  • Excellent, independent judgment based on knowledge and expertise.
  • Strong personal time-management and project-management skills.
  • Mastery of Microsoft Word, PowerPoint, and Excel.

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