Medical Director, Global Patient SafetyLocation: Hybrid BarcelonaThis is what you will do:The Medical Director, Global Patient Safety is accountable for executing the safety and risk management activities for one or more assigned clinical development projects or marketed products to enable the safe and effective use of Alexion's products by patients and healthcare providers. The jobholder utilizes subject matter clinical and pharmacovigilance expertise, combined with knowledge of the product(s) or therapeutic area to identify and evaluate safety signals and to drive decision-making on risk/benefit evaluation and argumentation, pharmacoepidemiological or clinical trial data interpretation, and risk assessment. The Medical Director, Risk Management Pharmacovigilance is an individual contributor role and reports to the Senior Medical Director, Risk Management Pharmacovigilance.You will be responsible for:Leading risk management evaluation and resolution for assigned products and projects.Identifying potential signals for observed adverse events for further review and analysis.Directing the Safety Management Team for the assigned project(s) or product(s), ensuring a safety and risk/benefit driven agenda from inception to closure.Representing GPV on other project/product team(s) or subteam(s), ensuring processes for timely collection and processing of adverse events, assessment of suspected adverse reactions, and identification of contraindications, precautions, warnings, and other risk mitigations.Collaborating with external resources such as Clinical Operations and Clinical Scientist on the identification of and resolution for potential signals.Detecting, validating, and managing pre- and/or post-approval safety signals through to resolution.Ensuring timely, accurate recording of risk management action plans and decisions.Conducting medical assessment of causality of Individual Case Safety Report (ICSR) as necessary.Evaluating aggregate safety data and writing contributions to its interpretation for various safety and risk/benefit evaluations.Providing medical interpretation of complex PV and pharmacoepidemiological data to enable clinical and regulatory decision-making.Identifying, initiating, and managing necessary updates to labeling documentation.Conducting medical evaluation of issues arising from PV Operations.Providing medical input to ARGUS search criteria as necessary.You will need to have:MD RequiredFive years relevant safety and risk management experience in the pharmaceutical industry.Knowledge and understanding of PV deliverables, standards, and processes.Broad and deep knowledge of the principles, concepts, and theories of drug-induced disease for therapeutic/product area(s).Excellent, independent judgment based on leading-edge knowledge and expertise.Strong verbal and written communication skills.Sound problem-solving skills including the ability to make decisions by developing innovative options and/or multiple solutions to highly complex problems.Ability to manage multiple overlapping complex tasks to conclusion, sometimes to tight timelines.We would prefer for you to have:4+ years in clinical medicine (post-training/residency).Rare, Ultra-Rare or Orphan Disease Area experience.Strong personal time-management and project-management skills.Collaborative skills to partner with internal and external teams.
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