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Global Safety Manager

France, Paris 08 50000.00 - 65000.00 EUR / Année · Offre publiée 05 mars 2026
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Description du poste

Vos activités seront les suivantes : Superviser les activités de gestion des cas sur deux plateformes et suivre les KPI; Présenter les résultats aux responsables Safety EU, QPPV délégués et équipes PV QA; Répondre aux questions des équipes locales et prestataires concernant les cas; Apporter un support opérationnel quotidien : traitement des cas, résolution de problèmes, contrôle qualité; Suivre les délais de traitement et analyser les causes de retard; Participer à des réunions régulières avec les prestataires et remonter les problématiques si nécessaire; Assurer la réconciliation des cas avec les partenaires (SDEA/PVA) et bases cliniques; Examiner les CAPA liées au traitement des cas; Collaborer avec les équipes outils PV pour intégrer les évolutions réglementaires; Contribuer à la formation des équipes locales et des plateformes; Participer aux audits et inspections

Responsabilités

  • Superviser les activités de gestion des cas sur deux plateformes et suivre les KPI
  • Présenter les résultats aux responsables Safety EU, QPPV délégués et équipes PV QA
  • Répondre aux questions des équipes locales et prestataires concernant les cas
  • Apporter un support opérationnel quotidien : traitement des cas, résolution de problèmes, contrôle qualité
  • Suivre les délais de traitement et analyser les causes de retard
  • Participer à des réunions régulières avec les prestataires et remonter les problématiques si nécessaire
  • Assurer la réconciliation des cas avec les partenaires (SDEA/PVA) et bases cliniques
  • Examiner les CAPA liées au traitement des cas
  • Collaborer avec les équipes outils PV pour intégrer les évolutions réglementaires
  • Contribuer à la formation des équipes locales et des plateformes
  • Participer aux audits et inspections

Exigences

  • Diplôme en sciences de la vie (Pharmacie, Médecine, Infirmier ou équivalent)
  • Minimum 7 ans d’expérience en Pharmacovigilance, dont une solide expérience en gestion globale des cas
  • Maîtrise des réglementations PV internationales (EMA, FDA, MHRA, PMDA, Santé Canada…) et des référentiels (ICH E2B, MedDRA, GVP, CIOMS)
  • Excellentes compétences en codage MedDRA, rédaction de narratifs et qualité des données
  • Expérience avec Argus Safety
  • Expérience dans la gestion d’activités externalisées et la relation prestataires
  • Connaissance de la gestion des déviations, CAPA et plans de remédiation

Ce que nous offrons

  • Programme d’intéressement
  • Carte tickets restaurant

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