PV/RA Manager - Benelux Operations & Compliance

Chiesi Belgium; Zaventem; Hybride; EUR 90 000 - 130 000; Plein temps

Avantages offerts par ce poste

Salary aligned with responsibilities

Bonus scheme

13th month salary

32 holidays

Lease car

Hybrid work model

Workation

Group insurance

DKV hospitalization

Family travel insurance

C‑Fit program

Learning budget €1k

Résumé du poste

Chiesi Belgium, a Benelux-based PV/RA leader, seeks an experienced PV/RA Manager to own daily pharmacovigilance and regulatory affairs operations across the Benelux. You will set priorities, safeguard quality, and collaborate with the department manager and external partners.

You will coach the PV/RA Specialist and the Medical Information & PV Officer, act as Local PV contact, and drive continuous improvements in our PV/RA systems while ensuring compliance with evolving regulations.

Qualifications

• Master’s degree in biomedical or pharmaceutical sciences.
• At least five years of PV and RA experience.
• Independent daily PV/RA management.
• Strong knowledge of PV practices and lifecycle management.
• Inspections and audits experience.
• Excellent written and spoken Dutch, French and English.

Responsabilités

• Coordinate, oversee and execute daily PV/RA activities within Chiesi Benelux.
• Set priorities, safeguard quality and regulatory compliance and ensure smooth collaboration with Global, authorities and external partners.
• Lead, coach and support the PV/RA Specialist and Medical Information & PV Officer.
• Act as Affiliate Pharmacovigilance Person for Chiesi Global and Local Contact Person for PV to Benelux authorities.
• Maintain and continuously improve local PV and RA Quality Systems.
• Oversee review, registration, reporting and follow‑up of safety information and AE reports.
• Coordinate PV training, agreements, reconciliations, service providers and Risk Management Plans.
• Lead audits, inspections and CAPA activities.
• Ensure products comply with regulatory requirements across Benelux.

Connaissances

Dutch language

French language

English language

People management

Formation

Master’s degree in biomedical or pharmaceutical sciences

Description du poste

Chiesi Belgium, a Benelux-based PV/RA leader, seeks an experienced PV/RA Manager to own daily pharmacovigilance and regulatory affairs operations across the Benelux. You will set priorities, safeguard quality, and collaborate with the department manager and external partners.

You will coach the PV/RA Specialist and the Medical Information & PV Officer, act as Local PV contact, and drive continuous improvements in our PV/RA systems while ensuring compliance with evolving regulations.