Teams at Excelya

Lead Excelya’s local pharmacovigilance function in Romania, ensuring regulatory compliance, safety monitoring, case management, signal detection, risk management, reporting, and quality-system effectiveness. Serve as the primary contact for health authorities and lead audits, inspections, investigations, CAPAs, training, and inspection readiness. Collaborate with cross-functional teams and vendors while driving regulatory intelligence, risk identification, and continuous improvement of local PV operations.

Lead and manage the QA Vigilance & Compliance team to define and implement quality and compliance requirements for vigilance activities. Ensure regulatory compliance (GVP, GMP, ISO), provide quality oversight, manage audits and external partner QA, support regulatory inspections (ANSM, FDA), monitor KPIs, and drive continuous improvement and regulatory intelligence.

Lead Excelya’s local pharmacovigilance function, ensuring regulatory compliance, safety monitoring, case management, signal detection, risk management, reporting, quality systems, audits, inspections, CAPAs, training, vendor oversight, and inspection readiness. Serve as the primary contact for health authorities and drive continuous improvement through regulatory intelligence, risk identification, and stakeholder collaboration. This is a part-time freelancer role requiring German and English fluency and EU residency.