Senior PV/RA Manager: Lead Compliance & Operations

Chiesi Farmaceutici S.p.A.; Zaventem; Hybride; EUR 90 000 - 120 000; Plein temps

Avantages offerts par ce poste

Hybrid working model

13th month of salary

Lease car

Group insurance

DKV hospitalization

Family travel insurance

Annual learning budget €1,000

Well-being program (C-Fit)

Résumé du poste

Chiesi Farmaceutici S.p.A. in Zaventem is seeking a PV/RA Manager to own daily pharmacovigilance and regulatory affairs operations for the Benelux, guiding a PV/RA Specialist and a Medical Information & PV Officer while collaborating with Chiesi Global and local authorities.

You bring a master’s in biomedical or pharmaceutical sciences, at least five years PV/RA experience, and fluent Dutch, French and English; leadership mindset; you will ensure quality systems, manage audits, training,

Qualifications

• Master’s degree in biomedical or pharmaceutical sciences.
• At least five years of PV and RA experience.
• Ability to independently manage daily PV and RA activities.
• Strong knowledge of Good Pharmacovigilance Practices and lifecycle management.
• Experience with Health Authority inspections and audits.
• Experience as an LCPV or similar role is preferred.
• Excellent written and spoken communication in Dutch, French and English.
• People-management or coaching potential.

Responsabilités

• Lead, coach and support the PV/RA Specialist and Medical Information & PV Officer in their daily work.
• Act as Affiliate Pharmacovigilance Person for Chiesi Global and Local Contact for Pharmacovigilance to Benelux authorities.
• Maintain and improve local PV and RA Quality Systems.
• Oversee review, registration, reporting and follow-up of safety information and adverse events.
• Coordinate PV training, agreements, reconciliations, and Risk Management Plans.
• Lead audits and CAPA activities and follow-up.
• Ensure compliance with regulatory requirements across the Benelux.
• Coordinate registration dossiers and packaging materials in close cooperation with Chiesi Global.
• Monitor regulatory developments and translate into operational actions.
• Optimize processes to improve quality, efficiency and continuity.

Connaissances

Leadership experience

People management

Dutch, French and English proficiency

Regulatory affairs knowledge

Pharmacovigilance knowledge

Formation

Master's degree in biomedical or pharmaceutical sciences

Outils

GVP knowledge

Health Authority inspections

Description du poste

Chiesi Farmaceutici S.p.A. in Zaventem is seeking a PV/RA Manager to own daily pharmacovigilance and regulatory affairs operations for the Benelux, guiding a PV/RA Specialist and a Medical Information & PV Officer while collaborating with Chiesi Global and local authorities.

You bring a master’s in biomedical or pharmaceutical sciences, at least five years PV/RA experience, and fluent Dutch, French and English; leadership mindset; you will ensure quality systems, manage audits, training,