PV/RA Manager

pSelect how often (in days) to receive an alert: /ppDepartment: QA, Regulatory Affairs Pharmacovigilance /ppBusiness Area: RD, Pharmacovigilance Regulatory Affairs /ppJob Type: Direct Employee /ppContract Type: Permanent /ppLocation:pZaventem, BE /p /ppPV/RA Manager /ppemAre 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? /em /ppbremAt 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. /em /ppbremWe would love to meet you /em /ph3bWhy this role stands out /b /h3ulliIndependently run the daily PV/RA operations. /liliCombine hands-on PV/RA work with the operational leadership of two colleagues. /liliAct as the first point of contact for operational questions and decisions. /liliContribute directly to patient safety, compliance and the availability of medicinal products. /li /ulh3bWhat will you do? /b /h3pAs 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. /ppbrYou will: /pulliLead, coach and support the PV/RA Specialist and Medical Information PV Officer in their daily work. /liliAct as Affiliate Pharmacovigilance Person for Chiesi Global and Local Contact Person for Pharmacovigilance towards the relevant Benelux authorities. /liliMaintain and continuously improve the local PV and RA Quality Systems. /liliOversee the review, registration, reporting and follow-up of safety information and adverse-event reports. /liliCoordinate PV training, agreements, reconciliations, service providers and Risk Management Plans. /liliLead the preparation and follow-up of audits, inspections and CAPA activities. /liliEnsure that current and future products comply with regulatory requirements across the Benelux. /liliCoordinate registration dossiers, product information and packaging materials in close cooperation with Chiesi Global. /liliMonitor regulatory developments and translate them into clear operational actions. /liliOptimise working processes and identify opportunities to improve quality, efficiency and business continuity. /li /ulh3bWe offer you /b /h3pJoin a passionate, Italian family-owned company where our values and behavior truly matter /ppAs 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 /ppIn 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. /pulliAn attractive salary in line with your responsibilities and experience. /liliPerformance-based bonus structure linked to individual objectives and company result. /lili13th month of salary /lili32 holidays per year, including 20 legal holidays and 12 RWH-days (Reduced

Working Hours
) /liliLease car /liliHybrid working model: everyone is working at least 3 days per week in the office. The other days you are free to work remotely. /liliWorkation: 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. /liliGroup insurance with no employee contribution and coverage in case of death and disability, ensuring you and your family are always well protected. /liliDKV hospitalization is fully paid by the employer for you and your family. /liliFamily travel insurance is fully paid by the employer for you and your family. /liliC-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. /liliAnnual budget of € 1.000 that you can use for learning or well-being opportunities, helping you grow professionally and personally. /li /ulh3bWho are we looking for? /b /h3pA 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. /ppbrYou bring: /pulliA master’s degree in biomedical or pharmaceutical sciences, or an equivalent level gained throug