PV/RA Manager

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

Department: QA, Regulatory Affairs & Pharmacovigilance

Business Area: R&D, Pharmacovigilance & Regulatory Affairs

Job Type: Direct Employee

Contract Type: Permanent

Location: Zaventem, BE

PV/RA Manager

Are you an experienced Pharmacovigilance and Regulatory Affairs professional ready to take ownership of the daily PV/RA operations? Do you combine in-depth expertise with a hands-on mentality and the ability to guide and develop others?

At Chiesi, you will independently manage the day-to-day PV/RA activities across the Benelux. You work closely with the department manager, who remains responsible for the strategic direction, and provide operational leadership to the PV/RA Specialist and the Medical Information & PV Officer.

We would love to meet you!

Why this role stands out

• Independently run the daily PV/RA operations.
• Combine hands-on PV/RA work with the operational leadership of two colleagues.
• Act as the first point of contact for operational questions and decisions.
• Contribute directly to patient safety, compliance and the availability of medicinal products.

What will you do?

As PV/RA Manager, you coordinate, oversee and execute the daily Pharmacovigilance and Regulatory Affairs activities within Chiesi Benelux. You set priorities, safeguard quality and compliance and ensure smooth collaboration with Chiesi Global, authorities and external partners.

You will:

• 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 Person for Pharmacovigilance towards the relevant Benelux authorities.
• Maintain and continuously improve the local PV and RA Quality Systems.
• Oversee the review, registration, reporting and follow-up of safety information and adverse-event reports.
• Coordinate PV training, agreements, reconciliations, service providers and Risk Management Plans.
• Lead the preparation and follow-up of audits, inspections and CAPA activities.
• Ensure that current and future products comply with regulatory requirements across the Benelux.
• Coordinate registration dossiers, product information and packaging materials in close cooperation with Chiesi Global.
• Monitor regulatory developments and translate them into clear operational actions.
• Optimise working processes and identify opportunities to improve quality, efficiency and business continuity.

We offer you

Join a passionate, Italian family-owned company where our values and behavior truly matter!

As family-owned company we focus on making impact for patients, the planet, people and all that with shared prosperity. Our activities have been externally validated as B Corp certified. At Chiesi, we believe in continuous growth and development. Your personal and professional journey matters to us!

In addition to our focus on professional success, we place great importance on team connection and collaboration. That’s why we organize several internal offsite business events to foster connection, feedback and collaboration.

• An attractive salary in line with your responsibilities and experience.
• Performance-based bonus structure linked to individual objectives and company result.
• 13th month of salary
• 32 holidays per year, including 20 legal holidays and 12 RWH-days (Reduced Working Hours)
• Lease car
• Hybrid working model: everyone is working at least 3 days per week in the office. The other days you are free to work remotely.
• Workation: option work from another location for up to three weeks per year, giving you the freedom to balance work and life in a way that suits you best.
• Group insurance with no employee contribution and coverage in case of death and disability, ensuring you and your family are always well protected.
• DKV hospitalization is fully paid by the employer for you and your family.
• Family travel insurance is fully paid by the employer for you and your family.
• C-Fit Program: Track your well-being in our app, enjoy a shared healthy lunch at the office, and participate in well-being activities that combine fun with colleagues while helping you achieve a healthy lifestyle.
• Annual budget of € 1.000 that you can use for learning or well-being opportunities, helping you grow professionally and personally.

Who are we looking for?

A senior PV/RA professional who can work autonomously, make sound operational decisions and keep the department moving forward. You enjoy working hands-on and bring positive energy, drive and a genuine passion for PV and RA. You may already have leadership experience or be ready to grow into this responsibility.

You bring:

• A master’s degree in biomedical or pharmaceutical sciences, or an equivalent level gained through experience.
• At least five years of relevant experience within both Pharmacovigilance and Regulatory Affairs.
• The ability to independently manage daily PV and RA activities.
• Strong knowledge of Good Pharmacovigilance Practices and medicinal product lifecycle management.
• Experience with Health Authority inspections and audits.
• Experience as an LCPV or in a comparable pharmacovigilance-responsible role is preferred.
• Excellent written and spoken communication skills in Dutch, French and English.
• A proactive, positive and solution-oriented mindset.
• People-management or coaching experience, or the ambition and potential to develop in this area.

Chiesi uses diversity and inclusion as a source of innovation and creativity. Therefore, we welcome all applications regardless of ethnic origin, age, gender, disability, sexual identity, ideology or religion.

About Chiesi

Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. More than 7,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. Discover more here.

At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. This fosters a culture of reliability, transparency, and ethical behaviour at every level. As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact.

Diversity and inclusion are at the heart of who we are. We believe our differences make us stronger. We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better.

PV/RA Manager

Questions? Please contact Femke Roze at [e-mail].