SDEA Pharmacovigilance Specialist

Join Excelya, where Audacity, Care and Energy define who we are and how we work. We believe in creating ambitious solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.
We are seeking a SDEA Pharmacovigilance Specialist to lead and oversee Safety Data Exchange Agreement (SDEA) activities within a global pharmacovigilance environment. This role is critical in ensuring compliant safety data exchange processes with partners, vendors, distributors, and license holders while maintaining alignment with global regulatory requirements and internal standards.
Key responsabilities:
Lead the creation, review, negotiation, and maintenance of Safety Data Exchange Agreements (SDEAs).
Ensure compliance with global pharmacovigilance regulations and company procedures.
Collaborate with internal stakeholders including Pharmacovigilance, Legal, Quality, Regulatory Affairs, and Business Development teams
Act as the primary point of contact for SDEA-related discussions with external partners.
Manage agreement timelines, renewals, amendments, and compliance tracking activities.
Identify and mitigate risks associated with safety data exchange obligations.
Support audits and inspections by providing SDEA documentation and subject matter expertise.
Contribute to process improvements and the development of best practices within the SDEA framework.
Requirements
Profile:
Master's degree in Life Sciences, Pharmacy, or a related field.
Strong experience in Pharmacovigilance and Safety Data Exchange Agreements.
Solid understanding of global pharmacovigilance regulations and ICH guidelines.
Experience working with commercial partners, distributors, licensing agreements, or vendor management.
Ability to interpret contractual language and translate regulatory requirements into operational processes.
Strong stakeholder management and cross-functional collaboration skills.
Excellent communication, negotiation, and relationship-building abilities.
Highly organized with strong attention to detail and compliance.
Fluent in English and French; additional languages are a plus.
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.

Work arrangement
No