Pharmacovigilance Lead

2d2 days ago

Excelya

Brussels, BE · Full-time · €85,000 – €115,000

About this role

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. This role ensures continuous improvement of processes, systems, and compliance across key PV activities while supporting inspection readiness, PSMF management, and partner oversight.

The position leads transformation projects to drive innovation and excellence across Global Pharmacovigilance. It delivers short- and mid-term initiatives that implement process and SOP improvements while advancing digital solutions through IT collaboration.

You will work within a young, ambitious health company of 900 Excelyates that operates as Europe’s leading mid-size CRO. The one-stop provider model offers full-service, functional service provider, and consulting projects alongside preeminent experts.

Excelling with care provides an environment that values natural talents, pushes boundaries with audacity, and nurtures potential to enhance the patient’s journey through improved scientific and operational knowledge.

Requirements

Degree in Life Sciences (Bachelor’s or higher).
10+ years of experience in the biopharmaceutical industry.
Strong expertise in signal detection, safety writing, and risk management across the drug development lifecycle.
Proven track record in driving operational improvements and governance initiatives.
In-depth knowledge of global GCP/GVP regulations and industry standards.
Demonstrated experience in change management and leading transformation initiatives.
Strong communication skills (written, verbal, presentation) with fluency in English.
Ability to work independently, manage multiple priorities, and collaborate in a matrix environment.

Responsibilities

Lead transformation projects to drive innovation and excellence across Global Pharmacovigilance (GPV).
Deliver short- and mid-term initiatives, ensuring effective implementation of process and SOP improvements.
Drive capability-building initiatives, including development of methodologies, tools, and frameworks.
Manage projects end-to-end, including planning, tracking milestones, and stakeholder communication.
Support and enhance GPV infrastructure, including procedures, data flows, tools, and documentation.
Collaborate with IT to advance digital solutions, automation, workflow optimization, and AI integration.
Ensure compliance across key PV activities, including case processing, safety systems, and local operations.
Contribute to PSMF maintenance, inspection readiness (CAPA, deviations), and partner management.

Benefits

Evolve through diverse projects via the one-stop provider service model offering full-service, functional service provider, and consulting opportunities.
Work alongside preeminent experts to improve scientific, operational, and human knowledge.
Benefit from an environment that values natural talents, pushes boundaries with audacity, and nurtures potential.