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Senior director, Patient Safety Compliance Excellence

AstraZeneca

US - Gaithersburg - MD permanent

Posted: January 16, 2026

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Job Description

The Senior Director, Pharmacovigilance Compliance is a critical leadership role within Patient Safety, responsible for the global governance and continuous improvement of compliance controls across the AstraZeneca pharmacovigilance landscape. The role drives both strategic and operational compliance by implementing robust predictive and detective controls, fostering an enterprise-wide safety and compliance culture and s haping policy . Key elements include championing the use of analytics, innovating compliance frameworks, developing compliance policies and standards, and partnering with QPPV to ensure optimal compliance and readiness globally through prediction and early detection. Typical Accountabilities Accountable for the global pharmacovigilance compliance model, encompassing preventive, detective, and corrective controls. Leads innovation in predictive compliance using advanced analytics and digital platforms to proactively identify and manage risks. Develops and maintains detective monitoring frameworks, including dashboards, that cover quality issues, audit findings , and root cause analysis information . Promotes and supports the development of global PV policies/procedures ensuring international alignment and regulatory compliance. Drives timely and sustainable preventive and corrective actions, embedding improvements into compliance frameworks and governance . Maintains compliance governance models and ensures effective engagement in governance meetings, such as PV council. Sponsors safety and compliance culture across Patient Safety; supports training, communication, and best /global standa rd practice dissemination. Partners closely with Inspection Excellence to ensure integrated compliance and inspection readiness approaches. Represents Patient Safety externally with regulators and in professional forums; ensures continual advocacy and knowledge leadership. Develops and mentors a high-performing, globally distributed team, championing talent and professional development. Provides comprehensive compliance reporting and strategic recommendations to QPPV/senior leadership. Essential Bachelor's degree (or equivalent) in a scientific/healthcare discipline 10+ years experience in pharmacovigilance, regulatory compliance, patient safety Demonstrated global QA and compliance leadership Thorough knowledge of directive, preventive, detective, and corrective controls Proven digital compliance/predictive analytics track record Cross-functional global experience (matrix working) Strong US/global compliance environment experience Excellence in communication, advocacy, and talent development Desirable PhD or equivalent in scientific discipline Extensive experience in pharmacovigilance, regulatory compliance, patient safety Experience with digital transformation, Lean/process improvement Demonstrated global QA and compliance leadership Financial awareness/oversight Thorough knowledge of directive, preventive, detective, and corrective controls Familiarity with new/emerging regulatory requirements Proven digital compliance/predictive analytics track record Experience with external engagement (industry, regulators) Cross-functional global experience (matrix working) Strong US/global compliance environment experience Excellence in communication, advocacy, and talent development Are you ready to bring new insights and fresh thinking to the table? Brilliant! We have one seat available, and we hope it’s yours. Apply today. AstraZeneca 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. We follow all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. The annual base pay (or hourly rate of compensation) for this position ranges from $ 197,318.40 - $295,977.60 . Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans. Date Posted 16-Jan-2026 Closing Date 22-Jan-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

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