Pharmacovigilance Manager

Excelya

Pharmacovigilance manager at Excelya ensuring quality safety data review and compliance in clinical research. Collaborating with teams and driving innovation in a hybrid work environment.

Posted 6/18/2026full-timeGhent • 🇧🇪 BelgiumMid-LevelSeniorWebsite

About the role

Key responsibilities & impact

- Ensure quality review of safety data received from partners before entry into the safety database (completeness, accuracy, compliance).
- Oversee serious adverse event (SAE) management, including coordination and review of case narratives.
- Perform quality checks of aggregate reports (e.g., DSURs).
- Support PV setup for clinical studies and implementation of safety processes.
- Manage PV documentation in eTMF to ensure inspection readiness.
- Contribute to the setup of post-marketing PV systems.
- Collaborate with internal teams and partners to ensure efficient and compliant safety operations.

Requirements

What you’ll need

- Degree in Life Sciences, Pharmacy, or related field.
- Solid experience in pharmacovigilance, including case processing and safety data review.
- Good knowledge of PV regulations (GVP, ICH) and clinical trial safety.
- Experience in quality control of safety data and exposure to safety databases/eTMF.
- Strong organizational and stakeholder coordination skills.
- Detail-oriented, proactive, and quality-driven mindset.
- Fluent in English.

Benefits

Comp & perks

**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.

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Applicant Tracking System Keywords

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Hard Skills & Tools

pharmacovigilancecase processingsafety data reviewquality controlsafety databaseseTMFaggregate reportspost-marketing PV systemssafety processesclinical trial safety

Soft Skills

organizational skillsstakeholder coordinationdetail-orientedproactivequality-driven mindset