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 representatives across international affiliates, ensuring local systems comply with both regional regulations and global processes.
Monitor PV activities across affiliates and share relevant data with Global Safety leads and other departments to identify local needs and regulatory gaps.
Organize regular meetings and training events with the local PV network to ensure alignment with group standards and regulatory expectations.
Oversee the safety of sponsored websites used for adverse event reporting and maintain global oversight of such platforms.
Support affiliates required to maintain a local Pharmacovigilance System Master File (PSMF).
Conduct impact assessments of new pharmacovigilance regulations and communicate necessary actions to operational teams.
Track regulatory changes and their implementation within the global PV system.
Support the functioning of the EEA QPPV Office, assisting both the International Department Lead and Deputy EEA QPPV.
Contribute to the drafting and tracking of Safety Data Exchange Agreements (SDEAs) and support the oversight of PV contracts with commercial partners.
Supervise and monitor the external provider managing pharmacovigilance agreements.
Perform other PV-related tasks as assigned by management, based on expertise.
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.
