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.

Minimum Requirements:

• 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 Skills:

• PhD or equivalent in scientific discipline
• Experience with digital transformation Lean/process improvement
• Financial awareness/oversight
• Familiarity with new/emerging regulatory requirements
• Experience with external engagement (industry regulators)

Date Posted

Closing Date

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 comply with all applicable laws and regulations on non-discrimination in employment (and recruitment) as well as work authorization and employment eligibility verification requirements.