Location: Barcelona, SpainJob reference: R-200592Date posted: 05/24/2024This 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:Leads risk management evaluation and resolution for assigned products and projects.
Accountable for the following:Through data review and research, identifies for monthly Safety, Risk Management and Safety Science Management Team meetings, issues that could be potential signals for observed adverse events for further review and analysisDirects the Safety Management Team for the assigned project(s) or product(s) ensuring a safety and risk/benefit driven agenda from inception to closureRepresents 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 contra indications, precautions, warnings and other risk mitigations, meeting internal and external standards and timelines; and accountable for allGPV deliverables relating to the project/productCollaborates with external resources such as Clinical Operations and Clinical Scientist on the identification of and resolution for potential signalsDetects, validates and manages pre-and/or post-approval safety signals through to resolutionEnsures timely, accurate recording of risk management action plans and decisions, and project manages GPV deliverables as appropriate to ensure completion on time to applicable standardsConducts medical assessment of causality of Individual Case Safety Report (ICSR) as necessary, including the assessment of quality within the ICSR process; identifies process improvement opportunities and drives changes in processEvaluates aggregate safety data and writes contributions to its interpretation for Periodic Safety Update Reports, Drug Safety Update Reports, Risk Management Plans, IB, CCSI, Safety Summaries and Clinical Overviews for the CTD, and other routine and non-routine safety and risk/benefit evaluations for internal or regulatory purposes as requiredProvides medical interpretation of complex PV and pharmacoepidemiological data to enable clinical and regulatory decision-makingIdentifies, initiates and manages to completion, necessary updates to the IB, CCSI and/or local product information, Medication Guide, Patient Leaflet, and other labeling documentation as necessaryConducts medical evaluation of issues arising from PV Operations, such as use of the MedDRA dictionary and the IME listProvides medical input to ARGUS search criteria as necessary, including development of appropriate searches where no SMQ existsYou will need to have:MD RequiredFive years relevant safety and risk management experience in the pharmaceutical industryKnowledge and understanding of PV deliverables, standards and processesBroad 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 expertiseStrong verbal and written communication including making recommended courses of action to management and/or senior leaders that impact the discipline, department or line, and influences their decisions.Sound problem solving skills including the ability to make decisions by developing innovative options and/or multiple solutions to highly complex problemsAbility 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 projectsWe would prefer for you to have:Prefer 4+ years in clinical medicine (post-training/residency)Rare, Ultra-Rare or Orphan Disease Area experienceStrong personal time-management and project-management skillsCollaborates and partners with internal and external teams to ensure consistency of actions and decision-making with overall development and/or commercial team strategiesAstraZeneca embraces diversity and equality of opportunity.
We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.
We believe that the more inclusive we are, the better our work will be.
We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.
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