Pharmacovigilance Project Manager
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What you'll do
- 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.
What they're looking for
- Pharmacovigilance experience within a pharmaceutical company, CRO, or regulatory environment, Strong hands-on experience in PV case processing, signal detection and safety data management
- Degree in Pharmacovigilance, Life Sciences, Clinical Development, Pharmacy, or related field.
- Experience with PV databases, ideally Argus Safety.
- Solid knowledge of MedDRA coding and terminology
- Good command of Microsoft Office tools (Excel, Word, PowerPoint, Outlook).
- Proactive, autonomous, and highly organized.
- Fluent in French & English, both written and spoken.
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
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.
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.
Requirements
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.
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.
Company
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