Pharmacovigilance Case Processing Officer H/F

Litterature surveillance processDate de parution: 22 juil. 2025Ville: GIF SUR YVETTEPays/Région: FRType de contrat: CDIN° offre: 9433Pharmacovigilance Case Processing OfficerThe PV Case Processing Officer handles responsability for the management of pharmacovigilance cases subcontracted to a vendor from collection to submissionPharmacovigilance Case Processing OfficerActivities & ResponsibilitiesThe Pharmacovigilance Case Processing Officer is responsible for :Monitoring the activities outsourced to the service providers :Management of pre and post-marketing pharmacovigilance cases in line with the Case Management team and Service provider : book-in, data entry, documentation, coding, narratives, evaluation, quality control, medical review and submission of the cases to ensure compliance with regulatory requirements, with Safety Data Exchange Agreements and procedures in placeManagement of cosmetovigilance casesLitterature surveillance processReconciliation with business partners, LPVs and clinical databases.Performing a weekly quality control of cases processed by the vendor.Reviewing legal cases with B/R unit representative.Drafting/Validating the deviation forms (root cause, CAPA) for cases submitted late to Regulatory authorities.Reviewing the protocol, the eCRF and writing the Safety Management Plan for clinical trials.Providing necessary documents and training to the vendor so that he has adequate information to perform the outsourced activities.Requesting the update of ARGUS database configuration for studies, products, reporting rules, Reference Safety Information.S/He participates to:Study team kick-off meeting and end of study meeting.Operational meetings with the vendors.Operational meetings with Business partners.Regular team meetings.LPVs and vendor training on case processing.Audits/inspections as Subject Matter Expert.S/He contributes to:Setting-up key performance indicators to follow vendor’s activities.Reviewing key performance indicators provided by the vendor.Monitoring of case processing done by the LPV for pharmacovigilance.Writing of quality documents related to case management.Validating vendor's invoicesProcess optimizationOnboarding of new collaborators.ProfileHealth Care professional, Scientific.At least 4 years of experience in PV case management in an international environment.Knowledge of information systems dedicated to PV and in IT project management.Excellent knowledge of regulatory requirements at the worldwide levelFluent in English.Good IT experience: pack office and internal toolsNous sommes engagés pour l’égalité des chances et le développement des talents dans toute leur diversité. Nous accordons autant de valeur à l’expérience qu’à l’envie de s’engager au quotidien pour être utile au progrès thérapeutique au bénéfice des patients. Si vous vous reconnaissez dans cette offre et ces quelques lignes, saisissez cette opportunité de nous rencontrer.Assistant administratif et accueil (F/H)Une ou un assistant de direction au sein du secrétariat particulier du Premier présidentParis, Île-de-France, France 14 hours agoAssistant de direction - Direction Education Jeunesse (H/F)Assistant/Assistante au cabinet du MaireCDI - Assistant(e) Comité de direction - H/FSECRETAIRE/ASSISTANT H/F Département Energie – PARIS (75020)Paris, Île-de-France, France 12 hours agoAssistant de traitement administratif des recours des militaires F/HAssistant juridique et administratif - H/FCDD- Chargé d'accueil et administratif à Nanterre F/HCoordinateur administratif et juridique F/HPuteaux, Île-de-France, France 3 hours agoAssistant administratif et pédagogique H/FVilleneuve-la-Garenne, Île-de-France, France 1 week agoParis, Île-de-France, France 13 hours agoChargé(e) d’assistanat de Direction (F/H)Levallois-Perret, Île-de-France, France 6 hours agoAssistant / Assistante de Direction - Direction générale F/HPalaiseau, Île-de-France, France 2 months agoAssistant administratif et de mobilité (F/H)Malakoff, Île-de-France, France 13 hours agoSecrétaire - Adjoint administratif - H/FAssistant Administratif et Pédagogique F/HRueil-Malmaison, Île-de-France, France 15 hours ago #J-18808-Ljbffr