
Senior Manager Clinical Safety Operations
Il y a 2 mois
En tant que Responsable Senior des Opérations de Sécurité, vous superviserez et gérerez les opérations de rapport de sécurité, en soutien aux essais cliniques d'Orano Med.
Ce rôle garantit la collecte, l'analyse et le rapport des données de sécurité de manière précise et dans les délais, en conformité avec les exigences réglementaires et les politiques de l'entreprise.
A ce titre, vos missions principales seront de:
Piloter les prestataires externes de sécurité et les processus pour assurer la conformité aux accords contractuels et aux exigences réglementaires
Assurer la conformité avec toutes les lignes directrices et exigences réglementaires pertinentes (par ex., FDA, EMA, ICH) relatives aux rapports de sécurité des essais cliniques
Développer et suivre les indicateurs clés de performance (KPI) pour le prestataire central de sécurité et les organisations de recherche clinique (CRO) gérant les études individuelles.
Développer et maintenir des procédures opérationnelles standard (SOP) et des instructions de travail pour la supervision des opérations de sécurité externalisées
Mettre en place des processus de sécurité au niveau des études et des mécanismes de rapport de sécurité (par ex. rédiger des plans de gestion de la sécurité, superviser la mise en place et la maintenance des portails de sécurité)
Gérer la rédaction des rapports de sécurité, y compris les rapports périodiques de sécurité (PSUR), les rapports de mise à jour sur la sécurité (DSUR)
Assurer la liaison avec les autorités réglementaires concernant les rapports de sécurité et fournir des réponses aux questions liées à la sécurité
Diriger des initiatives visant à mettre en œuvre de nouvelles technologies et outils pour soutenir la gestion et le rapport des données de sécurité.
Se tenir informé des tendances de l'industrie, des mises à jour réglementaires et des meilleures pratiques en pharmacovigilance et en opérations de sécurité.
En tant que Responsable Senior des Opérations de Sécurité, vous superviserez et gérerez les opérations de rapport de sécurité, en soutien aux essais cliniques d'Orano Med.
Ce rôle garantit la collecte, l'analyse et le rapport des données de sécurité de manière précise et dans les délais, en conformité avec les exigences réglementaires et les politiques de l'entreprise.
A ce titre, vos missions principales seront de:
Piloter les prestataires externes de sécurité et les processus pour assurer la conformité aux accords contractuels et aux exigences réglementaires
Assurer la conformité avec toutes les lignes directrices et exigences réglementaires pertinentes (par ex., FDA, EMA, ICH) relatives aux rapports de sécurité des essais cliniques
Développer et suivre les indicateurs clés de performance (KPI) pour le prestataire central de sécurité et les organisations de recherche clinique (CRO) gérant les études individuelles.
Développer et maintenir des procédures opérationnelles standard (SOP) et des instructions de travail pour la supervision des opérations de sécurité externalisées
Mettre en place des processus de sécurité au niveau des études et des mécanismes de rapport de sécurité (par ex. rédiger des plans de gestion de la sécurité, superviser la mise en place et la maintenance des portails de sécurité)
Gérer la rédaction des rapports de sécurité, y compris les rapports périodiques de sécurité (PSUR), les rapports de mise à jour sur la sécurité (DSUR)
Assurer la liaison avec les autorités réglementaires concernant les rapports de sécurité et fournir des réponses aux questions liées à la sécurité
Diriger des initiatives visant à mettre en œuvre de nouvelles technologies et outils pour soutenir la gestion et le rapport des données de sécurité.
Se tenir informé des tendances de l'industrie, des mises à jour réglementaires et des meilleures pratiques en pharmacovigilance et en opérations de sécurité.
**Adresse du poste **:125 avenue de Paris, Chatillon
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