Pharmacovigilance Project Manager

Excelya; France; Hybride; EUR 65 000 - 90 000; Plein temps

Résumé du poste

Excelya is seeking a Pharmacovigilance specialist to ensure patient safety and regulatory compliance across the product lifecycle. You will manage PV case processing, collect and assess adverse event reports, and perform quality reviews to support submissions.

The role involves local signal detection, literature surveillance, and collaboration with Global Safety, Medical Information, and Clinical Teams to maintain inspection-ready PV documentation.

Qualifications

• PV experience in pharma, CRO, or regulatory environment.
• Hands-on PV case processing, signal detection, and safety data management.
• Degree in Pharmacovigilance, Life Sciences, Clinical Development, or Pharmacy.

Responsabilités

• Manage PV case processing from receipt to reporting.
• Collect, assess, document, and follow up on adverse event reports.
• Perform quality review and medical consistency checks of safety cases prior to submission.
• Support local signal detection and safety monitoring initiatives.
• Participate in literature surveillance and regulatory intelligence activities.
• Contribute to periodic safety reports and PV activity reporting.
• Collaborate with Global Safety, Medical Information, Clinical Teams, and external partners.
• Maintain inspection-ready PV documentation, tracking, and archiving.
• Assist in reviewing and improving local PV procedures.

Connaissances

PV case processing

Signal detection

Safety data management

MS Office

Formation

Degree in Pharmacovigilance / Life Sciences

Outils

Argus Safety

MedDRA

PV databases

Description du poste

JoinExcelya, 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.

In this role, you will combine operational PV expertise with project coordination responsibilities to ensure patient safety and regulatory compliance throughout the product lifecycle.

Main Responsibilities:

• Manage and oversee pharmacovigilance case processing activities from receipt to reporting.
• Collect, assess, document, and follow up on adverse event reports from multiple sources.
• Perform quality review and medical consistency checks of safety cases prior to submission.
• Support local signal detection activities and contribute to safety monitoring initiatives.
• Participate in literature surveillance and regulatory intelligence activities.
• Contribute to periodic safety reports and monthly PV activity reporting.
• Collaborate with Global Safety, Medical Information, Clinical Teams, and external partners.
• Maintain complete and inspection-ready PV documentation, tracking, and archiving.
• Support the review and continuous improvement of local PV procedures and processes.
• Act as a key PV contact, ensuring clear communication, escalation, and stakeholder management.

Experience: Pharmacovigilance experience within a pharmaceutical company, CRO, or regulatory environment, Strong hands-on experience in PV case processing, signal detection and safety data management

Education: Degree in Pharmacovigilance, Life Sciences, Clinical Development, Pharmacy, or related field.

Technical Skills: Experience with PV databases, ideally Argus Safety., Solid knowledge of MedDRA coding and terminology, Good command of Microsoft Office tools (Excel, Word, PowerPoint, Outlook).

Soft Skills: Proactive, autonomous, and highly organized.

Languages: Fluent in French & English, both written and spoken.

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'sleading mid-size CROwith thebest employee experience. Ourone-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 caremeans 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.