International PV Project Manager

Excelya; Saclay; Sur place; EUR 40 000 - 65 000; Plein temps

Résumé du poste

Excelya, une entreprise dynamique et ambitieuse dans la recherche clinique, recherche un professionnel en pharmacovigilance pour coordonner les opérations internationales. Dans ce rôle, vous contribuerez à l'innovation et à l'impact dans un environnement stimulant, tout en soutenant les équipes locales pour respecter les réglementations de sécurité. Vous travaillerez avec des experts, en contribuant à des projets divers et à l'amélioration de la connaissance humaine et opérationnelle pour enrichir le parcours des patients.

Qualifications

• Capacité à évoluer dans des environnements collaboratifs et dynamiques.
• Expérience avec les systèmes PV et responsabilités EEA QPPV.
• Parfaitement bilingue en anglais et français.

Responsabilités

• Coordonner le réseau des officiers de sécurité locaux.
• Surveiller les activités de pharmacovigilance.
• Aider à la gestion des accords de pharmacovigilance.

Connaissances

Compréhension des systèmes de pharmacovigilance

Connaissance des obligations réglementaires

Compétences en communication internationale

Formation

Master en sciences de la vie (Pharmacie ou domaine connexe)

Description du poste

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 Global Safety. 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:

• Coordinate the network of Local Safety Officers (LSOs) across international affiliates, ensuring the maintenance of a local PV system in line with local regulations and global processes
• Monitor key PV activities within the affiliates and share relevant data with other Global Safety stakeholders to identify local needs and potential compliance gaps
• Organize periodic events and meetings with affiliate LSOs to collect insights, ensure efficient collaboration, and provide updates/training on global PV practices
• Oversee the safety of company-sponsored websites for adverse event reporting by maintaining a global follow-up process
• Support affiliates in meeting local regulatory obligations, particularly the maintenance of a local Pharmacovigilance System Master File (PSMF)
• Conduct impact assessments of new pharmacovigilance regulations and ensure communication of any regulatory implications to the relevant operational teams
• Monitor implementation of regulatory changes within the global PV system
• Contribute to the functioning of the EEA QPPV Office by supporting the International Safety Lead and Deputy EEA QPPV
• Assist in the management of pharmacovigilance agreements (SDEAs) with commercial partners, including drafting, updates, and tracking
• Supervise and follow up with external service providers responsible for PV agreement (PVA) management
• Participate in additional PV-related missions as requested by management, based on expertise
  
  

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 (talent matters most to us!)
• Skills: Solid understanding of global pharmacovigilance systems, regulatory requirements, and local affiliate operations, familiar with pharmacovigilance regulatory frameworks, including EEA QPPV responsibilities, PSMF, and local compliance obligations, knowledge of PV contractual requirements and experience drafting or managing SDEAs
• Education: Master's degree in Life Sciences (Pharmacy or related field)
• Languages: Fluent in written and spoken English and French; strong communication skills with international 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.