Local PV Head (LSO)

Excelya; Belgique; Sur place; EUR 90 000 - 130 000; Plein temps

Résumé du poste

Excelya in Belgium is seeking a Senior Pharmacovigilance Lead to drive the local PV function, ensuring regulatory compliance and high safety governance. You will coordinate audits, inspections, and interactions with Health Authorities, and mentor cross-functional teams.

The role requires a Life Sciences degree and at least 5 years in PV, fluency in German and English, and strong leadership capabilities. This is a Belgium-based, full-time role with opportunities for growth within a global CRO.

Qualifications

• Degree in Life Sciences, Pharmacy, Medicine or related field.
• EU-based with German and English fluency (spoken and written).
• At least 5 years in pharmacovigilance; asset if in a similar role.
• Strong knowledge of PV regulations; audits and vendor management experience.
• Excellent organizational and leadership skills; cross-functional collaboration.

Responsabilités

• Lead and maintain the local Pharmacovigilance function in compliance with regs and company standards.
• Serve as PV contact for Health Authorities and lead PV inspections, audits, regulatory interactions.
• Oversee local safety monitoring: case management, signal detection, risk management, reporting.
• Ensure PV quality systems: monitoring, investigations, CAPAs, training, inspection readiness.
• Partner with cross-functional teams and vendors to implement PV processes and governance.
• Drive continuous improvement through risk identification, regulatory intelligence, stakeholder engagement.

Connaissances

German language

English language

Leadership

Regulatory knowledge

Cross-functional collaboration

Formation

Degree in Life Sciences/Pharmacy/Medicine

Description du poste

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 and ambitious team. 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

• Lead and maintain the local Pharmacovigilance function, ensuring full compliance with applicable regulatory requirements and company standards.
• Serve as the primary PV contact for Health Authorities and lead PV inspections, audits, and regulatory interactions.
• Oversee local safety monitoring activities, including case management, signal detection, risk management, and reporting obligations.
• Ensure the effectiveness of local PV quality systems, including compliance monitoring, investigations, CAPAs, training, and inspection readiness.
• Partner with cross-functional teams and external vendors to implement robust PV processes and ensure appropriate safety governance.
• Drive continuous improvement of local PV operations through proactive risk identification, regulatory intelligence, and stakeholder engagement.

• Degree in Life Sciences, Pharmacy, Medicine, or related field.
• Based in EU with Fluency in German language (spoken and written) and fluency in English (spoken and written) is required.
• At least 5 years of experience in pharmacovigilance, prior experience in a similar position will be considered an asset
• Strong knowledge of local and global PV regulations.
• Experience with audits, inspections, and vendor management.
• Excellent organizational and leadership skills.
• Strong communication and collaboration skills across cross-functional teams.

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.