Senior Medical Director, Global Patient Safety

hace 1 mes

Barcelona, España Mymenopauserx, Llc A tiempo completo

.This is what you will do: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 Directors and Safety 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 Patient 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 Patient Safety.You will be responsible for:Leads, 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).Leads a team of Medical Directors, and Safety Scientists in identifying, evaluating and facilitating resolution of safety signals, including effective communication of risk management plans.Provides 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.Partners with internal leaders within Global Patient Safety as well as other Alexion functions and affiliates to deliver integrated pharmacovigilance and risk management support to the Alexion business.Leads Product Safety Management Teams with Medical Directors to support key decision-making, drive evidence-based conclusions and develop pivotal next steps.Oversees work carried out on products and/or issues under highest scrutiny from a patient safety or regulatory perspective.Ensures ongoing and adequate safety surveillance, and timely detection and communication of new safety issues by his/her team.Ensures timely and adequate generation of aggregate reports, regulatory responses and risk management documentation by team, according to international requirements and internal standards.Responsible for ensuring adequate definition and implementation of risk minimization activities for assigned product portfolio

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