Safety Officer
il y a 1 mois
Créée en 2014, Excelya est une organisation de recherche sous contrat (CRO) « people centered ».
Nous proposons une expérience personnelle et authentique au sein d'une jeune entreprise de santé ambitieuse en passe de devenir le leader de la recherche clinique en Europe grâce à nos 800 Excelyates. Notre modèle unique de service de fournisseur à guichet unique - tirant parti d'un service complet et fonctionnel de fournisseur de services et de conseils - permet à nos Excelyates d'évoluer à travers un large éventail de projets. En collaboration avec des experts de premier plan, Excelya fait progresser les connaissances scientifiques, managériales et humaines pour améliorer le parcours du patient.
Pour les membres de notre équipe, exceller avec soin, c'est bénéficier d'un environnement professionnel stimulant qui encourage la participation personnelle, intellectuelle et opérationnelle afin qu'ensemble nous puissions être les meilleurs dans notre domaine. Nous nous engageons à donner à chaque Excelyate les moyens d'exprimer ses talents naturels, de développer son plein potentiel et de s'investir dans notre projet unique.
Pour en savoir plus sur nous, visitez www.excelya.com
Missions :
-Contribuer aux activités de détection des signaux pour les composés en développement et commercialisés :
- Initier, préparer et si besoin coordonner la détection des signaux à partir de la base de données,
- Demander les données auprès des contributeurs,
- Élaborer des requêtes dans la base de données de pharmacovigilance afin de générer line-listings et tableaux de synthèse,
- Analyser les données, compléter et rédiger les sections des rapports de détection des signaux (SER, DSER),
- Créer ou mettre à jour des annexes, effectuer le contrôle qualité.
-Contribuer à l’élaboration de tous les livrables de pharmacovigilance :
- Initier, préparer et si besoin coordonner, contribuer à l’analyse des données et à la rédaction des rapports agrégés de sécurité (PSURs, PBRERs, DSURs, RMPs, Clinical Overview et autres rapports ad hoc, réponses aux questions des autorités et des filiales, enquêtes de PV, ou tout document d’analyse de données de sécurité),
-Contribuer à la relecture des documents concernant les produits de son portefeuille : brochure investigateur, consentement et information patient, rapport d’étude et documents de référence, les parties « sécurité » des protocoles des études cliniques interventionnelles et non interventionnelles, particulièrement celles décrivant les modes de recueil et de signalement des données de sécurité.
- Effectuer le contrôle qualité mensuel des effets ou événements indésirables relatifs à l'utilisation des produits de son portefeuille.
- Effectuer le cas échéant les réconciliations des cas PV échangés avec le partenaire ou les filiales.
- Préparer les datasheets des produits correspondant au CCDS/CCSI/RSI/IB ou PI local et suivre le flux de leur révision et approbation.
- Si besoin, participer aux équipes projet /medical safety team en tant que représentant / acteur PV, représenter la GS lors des réunions d’upgrade des IME et de réconciliation ARGUS SAFETY/ CLINTRIAL.
- Le cas échéant, participer aux groupes de travail interne Global Safety
Profil :
- Master ou diplôme de pharmacien en Pharmacovigilance
- 2 à 5 ans d’experience sur toutes les activités liées à la safety en industrie pharmaceutique ou CRO
- Bon niveau d’anglais
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