PV/RA Manager

ppSelect how often (in days) to receive an alert: /p pDepartment: QA, Regulatory Affairs Pharmacovigilance /p pBusiness Area: RD, Pharmacovigilance Regulatory Affairs /p pJob Type: Direct Employee /p pContract Type: Permanent /p pLocation: Zaventem, BE /p pPV/RA Manager /p pAre 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? /p pbr/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. /p pbr/We would love to meet you /p h3bWhy this role stands out /b /h3 ul liIndependently run the daily PV/RA operations. /li liCombine hands‑on PV/RA work with the operational leadership of two colleagues. /li liAct as the first point of contact for operational questions and decisions. /li liContribute directly to patient safety, compliance and the availability of medicinal products. /li /ul h3bWhat will you do? /b /h3 pAs 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. /p pbr/You will: /p ul liLead, coach and support the PV/RA Specialist and Medical Information PV Officer in their daily work. /li liAct as Affiliate Pharmacovigilance Person for Chiesi Global and Local Contact Person for Pharmacovigilance towards the relevant Benelux authorities. /li liMaintain and continuously improve the local PV and RA Quality Systems. /li liOversee the review, registration, reporting and follow‑up of safety information and adverse‑event reports. /li liCoordinate PV training, agreements, reconciliations, service providers and Risk Management Plans. /li liLead the preparation and follow‑up of audits, inspections and CAPA activities. /liliEnsure that current and future products comply with regulatory requirements across the Benelux. /li liCoordinate registration dossiers, product information and packaging materials in close cooperation with Chiesi Global. /li liMonitor regulatory developments and translate them into clear operational actions. /li liOptimise working processes and identify opportunities to improve quality, efficiency and business continuity. /li /ul h3bWe offer you /b /h3 pJoin a passionate, Italian family‑owned company where our values and behavior truly matter /p pAs 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 /p pIn 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. /p ul liAn attractive salary in line with your responsibilities and experience. /li liPerformance‑based bonus structure linked to individual objectives and company result. /li li13th month of salary /li li32 holidays per year, including 20 legal holidays and 12 RWH‑days (Reduced

Working Hours
) /li liLease car /li liHybrid working model: everyone is working at least 3 days per week in the office. The other days you are free to work remotely. /li liWorkation: 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. /li liGroup insurance with no employee contribution and coverage in case of death and disability, ensuring you and your family are always well protected. /li liDKV hospitalization is fully paid by the employer for you and your family. /li liFamily travel insurance is fully paid by the employer for you and your family. /li liC‑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. /li liAnnual budget of € 1.000 that you can use for learning or well‑being opportunities, helping you grow professionally and personally. /li /ul h3bWho are we looking for? /b /h3 pA 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. /p pbr/You bring: /p ul liA master’s degree in biomedical or pharmaceutical sciences