Pharmacovigilance Compliance Officer H/F Excelya

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in Pharmacovigilance. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Main Responsibilities:

- Manage non-conformities and related CAPAs (Corrective and Preventive Actions), including:

- Deviations related to late submissions of ICSRs to Health Authorities/Partners
- Delayed submission of periodic safety reports or any regulatory deliverables
- Procedural non-compliance and review of deviations opened by Local Safety Officers
- Coordinate the update and maintenance of the annual revision plan for quality documents managed by Global Safety
- Draft and maintain quality documents within scope, ensuring alignment with current regulatory requirements
- Generate, analyze, and share compliance performance indicators for the pharmacovigilance (PV) and PV quality systems
- Conduct qualification assessments of commercial partners and vendors involved in PV activities, ensuring proper documentation
- Coordinate responses to partner and regulatory risk analysis questionnaires
- Lead the coordination of audits and regulatory inspections by:
- Organizing the agenda and logistics
- Gathering required documentation
- Liaising with key stakeholders
- Managing and tracking audit/inspection observations and responses
- Ensuring audit documentation is properly archived in the designated system