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International Pharmacovigilance Project Manager
Posted 14 hours 23 minutes ago by Excelya
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.
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 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 PV officers across international affiliates.
- Ensure affiliate PV systems comply with local and global requirements.
- Monitor and report key PV activities across regions.
- Organize and facilitate regular meetings/training with local PV teams.
- Support affiliates maintaining a local PSMF.
- Conduct regulatory intelligence and impact analysis of new PV requirements.
- Support the EEA QPPV Office with operational tasks.
- Draft and track Safety Data Exchange Agreements (SDEAs) with commercial partners.
- Oversee service providers handling PV agreements (PVAs).
- Collaborate cross-functionally and support ad hoc PV projects as needed.
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 (avoid requiring minimum years-talent matters most to us!)
- Skills: Strong knowledge of PV regulatory requirements, particularly in the EU/EEA context, Experience working with international PV networks or within a Global Safety structure is a strong asset, Experience in drafting or reviewing SDEAs and interacting with vendors is a plus.
- Education: Degree in Pharmacy, Life Sciences, or equivalent.
- Languages: Fluency in French & English
Excelya
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