Manager, EU PV Governance & PSMF / Affiliate Oversight

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company's patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com.

Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.

Brief team/department description:

The Medical Affairs Group at Azurity is hiring a highly motivated Drug Safety Manager to join the team. This role is responsible for EU-based pharmacovigilance governance, ensuring that the Pharmacovigilance System Master File (PSMF), affiliate oversight, and vendor oversight activities accurately reflect operational reality. This position serves as the EU face of the PV system during regulatory inspections and ensures EU regulatory control over global PV operations.

Principle Responsibilities:

• Own and maintain the PSMF ensuring alignment with actual PV practices
• Provide EU oversight of vendor PV activities and ensure regulatory defensibility
• Manage and maintain Safety Data Exchange Agreements (SDEAs) and affiliate PV agreements
• Oversee EU reconciliation programs (clinical, MI, partners, vendors)
• Prepare QPPV metrics packages and governance reports
• Lead EU inspection readiness activities and serve as inspection front-room representative
• Oversee audit findings and CAPA management related to PV
• Ensure affiliate and partner PV oversight across EU territories
• Maintain signal and aggregate tracking visibility for EU regulatory expectations
• Ensure EU time-zone governance and accountability of the PV system

Qualifications and Education Requirements

• 8+ years of experience in Pharmacovigilance with strong EU regulatory exposure
• Deep knowledge of PSMF requirements and EU PV regulations
• Experience managing SDEAs, affiliates, and partner oversight
• Experience supporting EMA/MHRA inspections and audits
• Strong understanding of outsourced PV oversight models
• Excellent documentation and governance skills
• Ability to work closely with QPPV and global PV leadership

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