Pharmacovigilance Compliance Officer

Excelya; France; Sur place; EUR 40 000 - 60 000; Plein temps

Résumé du poste

A dynamic clinical research company in France seeks a professional in Pharmacovigilance to manage CAPAs, ensure regulatory compliance, and drive innovation. The ideal candidate will possess a PharmD and thrive in collaborative environments, with solid skills in global PV regulations and auditing processes. This role offers an opportunity to contribute to impactful clinical research and work alongside experts in the field.

Qualifications

• Proven ability to thrive in collaborative, fast-moving environments.
• Solid understanding of global PV regulations and quality systems.
• Experience in managing CAPAs, deviations, and regulatory compliance indicators.

Responsabilités

• Manage non-conformities and related CAPAs.
• Coordinate the update of the annual revision plan for quality documents.
• Draft and maintain quality documents ensuring regulatory compliance.

Connaissances

Collaboration skills

Understanding of global PV regulations

Management of CAPAs

Audit preparation

Formation

Doctor of Pharmacy (PharmD)

Description du poste

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

Requirements

About You

At Excelya, taking audacious steps is encouraged, so we\'re looking for individuals who are ready to grow with us and share our values.

• Experience: Proven ability to thrive in collaborative, fast-moving environments.
• Skills: Solid understanding of global PV regulations and quality systems, experience in managing CAPAs, deviations, and regulatory compliance indicators, familiar with the preparation and conduct of audits and inspections (internal and external).
• Education: Doctor of Pharmacy (PharmD) degree required.
• Languages: Fluent in written and spoken English and French; strong communication skills with global teams.

Benefits

Why Join Us?

At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.

Here's what makes us unique.

We are a young, ambitious health company representing 900 Excelyates, driven to become Europe\'s leading mid-size CRO with the best employee experience. Our one-stop provider service model offering full-service, functional service provider, and consulting enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient\'s journey.

Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.