As ADVANZ PHARMA continues to strengthen its position as the partner of choice for specialty, hospital, and rare disease medicines, we are seeking a Senior Executive, Patient Safety to join our Medical Office team.
The Senior Executive, Patient Safety plays an active role within the Patient Safety Team of ADVANZ PHARMA. This role shall be accountable for writing and supporting in activities related to safety data exchange agreements and PSMF. Must support in all activities related to Safety Data Exchange Agreements (SDEAs) and Pharmacovigilance System Master Files (PSMFs) in ADVANZ PHARMA's global operations. The role shall be responsible for ensuring that the activities are conducted in compliance with applicable pharmacovigilance regulations and internal procedures, maintaining inspection readiness. The position requires effective collaboration with internal stakeholders and external business partners to ensure ongoing compliance, operational excellence,
and maintenance of a robust pharmacovigilance framework.
What You'll Be Responsible For
• Writing, tracking, and maintaining SDEAs, along with reconciliation and PSMFs.
• Be the point of contact for partners and internal stakeholders to get the agreements reviewed and finalized.
• Maintain and update the SDEA tracking system, ensuring agreement obligations and responsibilities are appropriately captured in the responsibility matrix.
• Serve as the primary PV contact for internal stakeholders and external business partners regarding SDEA-related matters.
• Support in writing and maintenance of global and regional PSMFs, ensuring accuracy, completeness, and compliance with applicable regulatory requirements.
• Support the maintenance of PSMF annexes and supporting documentation and coordinate contributions from relevant stakeholders.
• Support the organisation during PV audits and inspections, including