Director, Safety Epidemiology – Global Markets

<p><b><span>Location: </span></b><span>Barcelona - Spain (3 days working from the office and 2 days working from home)</span></p><p></p><p><b><span>About the role</span></b><span> </span></p><p><span><span>AstraZeneca’s </span></span><b><span>Safety Epidemiology</span></b><span><span> team leads the strategy, design, execution, and delivery of post‑authorisation safety studies (PASS) across a broad portfolio of marketed and pipeline medicines. We are also responsible and accountable for generating epidemiological insights to investigate safety signals that helps to inform regulatory decision‑making, benefit–risk assessment, and risk management for AstraZeneca products across multiple therapy areas.</span><span> </span><span>We are seeking a </span></span><b><span>D</span><span>irector, </span><span>S</span><span>afety </span><span>E</span><span>pidemiology for </span><span>G</span><span>lobal </span><span>M</span><span>arkets</span></b><span><span> to provide </span><span>pharmacoepidemiology support to </span><span>local </span><span>and regional </span><span>markets</span><span>, including </span><span>real world evidence </span><span>and pharmacovigilance </span><span>teams in </span><span>Japan, Korea, China, and India</span><span>, </span><span>with potential expansion to </span><span>additional</span><span> </span><span>geographies</span><span>.</span></span><span> </span></p><p></p><p><b><span>Key responsibilities</span></b><span> </span></p><ul><li><p><b><span>Lead </span><span>PASS</span><span> strategy and delivery</span></b><span><span>: </span><span>Lead or advise on</span><span> </span><span>PASS strategy, </span><span>study design, protocol development, and execution to meet local regulatory requirements on time and to high quality standards.</span></span><span> </span></p></li></ul><ul><li><p><b><span>Provide scientific leadership</span></b><span><span>: Offer expert guidance on pharmacoepidemiology and pharmacovigilance methods, including study design optimization, bias control, feasibility, and execution across heterogeneous </span><span>global, </span><span>regional</span><span> </span><span>or</span><span> </span><span>local</span><span> </span><span>data sources.</span></span><span> </span></p></li></ul><ul><li><p><b><span>Line management responsibility: </span></b><span><span>Line management </span><span>of team members</span><span> reporting into Safety Epidemiology </span><span>responsible for </span><span>the planning and delivery of PASS for local </span><span>and</span><span> regional markets. </span></span><span> </span></p></li></ul><ul><li><p><b><span>Collaborate </span><span>effectively </span><span>with local-market RWE/PV leads</span></b><span><span>: Work closely with those </span><span>responsible</span><span> for generating real-world evidence and pharmacovigilance in local markets to ensure methodological consistency, data quality, and efficient escalation and resolution of </span><span>study</span><span>-specific issues.</span></span><span> </span></p></li></ul><ul><li><p><b><span>Operate across time zones and cultures</span></b><span><span>: Partner with local teams to navigate regulatory nuance while upholding global </span><span>AZ </span><span>standards; proactively </span><span>identify</span><span> risks, propose scientifically sound solutions, and drive decisions that keep studies on time, on scope, and compliant.</span></span><span> </span></p></li></ul><ul><li><p><b><span>Align local teams to global standards</span></b><span><span>: Support local teams to adopt and adhere to global standards for delivery, processes, documentation, and ways of working, ensuring consistency, audit readiness, and operational efficiency across markets.</span></span><span> </span></p></li></ul><ul><li><p><b><span>Drive cross-functional alignment</span></b><span><span>: Partner with Global Patient Safety, Regulatory, Medical, R&amp;D, and </span><span>internal </span><span>governance bodies to align strategies, accelerate decisions, and resolve scientific and operational challenges.</span></span><span> </span></p></li></ul><ul><li><p><b><span>Deliver </span><span>timely</span><span> evidence</span></b><span><span>: Lead or oversee </span><span>PASS</span><span> planning and delivery</span><span> to support Health Authority queries.</span></span><span> </span></p></li></ul><ul><li><p><b><span>Strengthen benefit–risk assessment</span></b><span><span>: Advise on benefit–risk characterization and contribute to qualitative and quantitative assessments across the product lifecycle.</span></span><span> </span></p></li></ul><ul><li><p><b><span>Build capability and manage delivery</span></b><span><span>: Coach colleagues across geographies</span><span>; </span><span>oversee CROs and external partners to ensure quality, timeliness, and reproducibility</span></span><span> </span></p></li></ul><ul><li><p><b><span>Shape the future pipeline</span></b><span><span>: </span><span>Anticipate</span><spa