Senior Medical Director, Global Patient Safety

.Location: Barcelona, Spain Job reference: R-210071 Date posted: 10/02/2024 The Senior Medical Director provides global strategic and operational oversight of Alexion's Safety Surveillance and Risk Management activities for assigned therapeutic area in fulfillment of global legislation and regulations. The jobholder defines the Safety Surveillance and Risk Management strategy and ensures its execution through leadership of a team of Medical Safety Directors and Safety Surveillance Scientists. This global team is accountable for the identification, analyses, assessment, communication and risk management of safety issues arising for the assigned product portfolio across their entire lifecycles. The jobholder provides medical and drug safety expertise to oversee and lead decision making based on complex risk/benefit evaluation, pharmacoepidemiological or clinical trial data interpretation, risk assessment and risk mitigation. In this capacity, the jobholder may represent the Global Drug Safety department as a subject matter expert on internal strategic or advisory committees. The jobholder has significant impact on cross-functional goals, including collaborating with the Clinical & Medical organization to enhance the safe and effective use of Alexion products and with the Commercial Organization to increase the probability of regulatory success. The Senior Medical Director reports to the Executive Medical Director, Global Drug Safety.Job Duties & ResponsibilitiesProvides Global Drug Safety leadership and contributes to key Alexion governance processes. Accountable for the following:Leads a team of Medical Directors and Safety Surveillance Scientists, and is responsible for people management activities; coaches, counsels and develops direct reportsRepresents Global Drug Safety at internal strategic and/or advisory/governance committeesChairs or participates in internal Safety Review Boards where applicableMay represent Alexion or act as an external technical resource at DSMB or Regulatory Authority meetings, or at external conferencesLeads, provides input and oversight of the ongoing safety surveillance, benefit risk assessment and risk management activities for assigned Alexion product portfolio for entire lifecycle (pre and post approval)