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Senior director, Patient Safety Compliance Excellence
2 weeks ago
The Senior Director, Pharmacovigilance Compliance is a criticalleadership rolewithin 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 shaping 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 AccountabilitiesAccountable 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 standard 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. EssentialBachelor's degree (or equivalent) in a scientific/healthcare discipline10+ years experience in pharmacovigilance, regulatory compliance, patient safetyDemonstrated global QA and compliance leadershipThorough knowledge of directive, preventive, detective, and corrective controlsProven digital compliance/predictive analytics track recordCross-functional global experience (matrix working)Strong US/global compliance environment experienceExcellence in communication, advocacy, and talent developmentDesirablePhD or equivalent in scientific disciplineExtensive experience in pharmacovigilance, regulatory compliance, patient safetyExperience with digital transformation, Lean/process improvementDemonstrated global QA and compliance leadershipFinancial awareness/oversightThorough knowledge of directive, preventive, detective, and corrective controlsFamiliarity with new/emerging regulatory requirementsProven digital compliance/predictive analytics track recordExperience with external engagement (industry, regulators)Cross-functional global experience (matrix working)Strong US/global compliance environment experienceExcellence in communication, advocacy, and talent developmentAre 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.
