Senior director, Patient Safety Compliance Excellence

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 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 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 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. 

Essential 

University degree (or equivalent) in a scientific/healthcare discipline 

Extensive 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 

University degree (or equivalent) in a scientific/healthcare discipline 

PhD or equivalent in scientific discipline 

Extensive experience in pharmacovigilance, regulatory compliance, patient safety 

Experience with digital transformation, Lean/pr