Senior director, Patient Safety Compliance Excellence

AstraZeneca • Gaithersburg, MD

7d

About The Position

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.

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

Nice To Haves

• 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/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

Responsibilities

• 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.

Benefits

• qualified retirement program [401(k) plan]
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees