PV/RA Manager

Location: Zaventem, Belgium; hybrid work with at least three days per week in the office. Remote work from another location is available for up to three weeks per year.

Company

hirify.global is an international, research-focused biopharmaceutical group operating in more than 30 countries, with a focus on innovative medicines and sustainable healthcare.

What you will do

• Manage and execute daily pharmacovigilance and regulatory affairs activities across the Benelux.
• Lead, coach, and support the PV/RA Specialist and Medical Information & PV Officer.
• Act as Affiliate Pharmacovigilance Person for hirify.global Global and local pharmacovigilance contact for relevant Benelux authorities.
• Maintain PV and RA quality systems and oversee safety information, adverse-event reporting, training, agreements, reconciliations, service providers, and risk management plans.
• Prepare and follow up on audits, inspections, and CAPA activities while ensuring product compliance.
• Coordinate registration dossiers, product information, packaging materials, and responses to regulatory developments.

Requirements

• Master’s degree in biomedical or pharmaceutical sciences, or equivalent experience.
• At least five years of experience in both pharmacovigilance and regulatory affairs.
• Ability to independently manage daily PV and RA activities and make operational decisions.
• Strong knowledge of Good Pharmacovigilance Practices and medicinal product lifecycle management.
• Experience with health authority inspections and audits.
• Excellent written and spoken Dutch, French, and English; people-management or coaching experience is valued.

Nice to have

• Experience as an LCPV or in a comparable pharmacovigilance-responsible role.
• Potential or ambition to develop further in people management.

Culture & Benefits

• Italian family-owned company with B Corp certification and a focus on patients, people, the planet, and shared prosperity.
• Hybrid working model with at least three office days per week.
• Performance-based bonus, 13th month of salary, lease car, allowances, and meal vouchers.
• 32 holidays per year, including legal holidays and reduced working-hours days.
• Group, hospitalization, outpatient care, and family travel insurance covered by the employer.
• Annual €1,000 budget for learning or well-being opportunities, plus internal offsite events and well-being activities.

Hiring process

• Submit a CV and motivation letter through the application process.