Senior Pharmacovigilance Quality Specialist – Inspection Management
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responsabilités:
🔹 Piloter les activités d'Inspection Readiness afin de garantir une préparation optimale aux inspections réglementaires. 🔹 Préparer, coordonner et accompagner les inspections de pharmacovigilance menées par les autorités de santé internationales (FDA, EMA, MHRA…). 🔹 Participer activement à la gestion des inspections, notamment aux activités de Front Room / Back Room. 🔹 Assurer la conformité des processus et systèmes PV avec les exigences réglementaires internationales (GVP, GCP, GLP). 🔹 Collaborer avec les équipes Pharmacovigilance, Regulatory Affairs, Clinical et Quality à l'échelle mondiale. 🔹 Réaliser des revues documentaires et contribuer à l'amélioration continue des processus qualité. 👤 Le
profil recherché
✅ 5 à 8 ans d'expérience minimum en pharmacovigilance, assurance qualité GVP ou gestion d'audits et d'inspections. ✅ Expérience confirmée dans la gestion des inspections PV indispensable, idéalement avec une expérience directe d'accueil et de coordination d'inspections réglementaires. ✅ Excellente connaissance des exigences GVP et des standards de conformité internationaux. ✅ Capacité à travailler avec des interlocuteurs multiples dans un environnement international. ✅ Anglais courant indispensable, à l'écrit comme à l'oral. ⭐ Les atouts supplémentaires :
• Expérience en audits internes ou externes.
• Connaissance des systèmes PV, des prestataires et des Quality Management Systems (QMS).
• Maîtrise du français appréciée. 🌍 Pourquoi rejoindre cette mission ? Vous intégrerez une équipe qualité internationale à taille humaine, avec une réelle exposition aux activités globales de pharmacovigilance et aux inspections réglementaires. 📩 Intéressé(e) ou vous connaissez quelqu'un qui pourrait correspondre ? Contactez-moi directement en message privé ou partagez cette opportunité avec votre réseau
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