Pharmacovigilance Case Processing Manager
il y a 2 jours
Pharmacovigilance Case Processing Manager (F/M)We are a human-sized, international and independent pharmaceutical group governed by a Foundation. Our mission: to advance therapeutic progress for patients. As a world leader in cardiology, we aim to focus on oncology by 2030, dedicating more than 70% of our R&D budget to difficult-to-treat cancers, while developing our generic activity to improve access to quality care at lower cost. We are 21 900 passionate people from over 50 nationalities, driven by entrepreneurship. Join us to contribute to our commitment #MovedByYou.Location: Saclay, FR | Contract: CDI | Job reference: 9734Missions & ActivitiesWithin the Global Safety Department, the PV Case Processing Manager reports to Case Management and Pharmacovigilance Systems Director, leads a dedicated team and achieves the following:ResponsibilitiesCase managementSetting a robust case management processMonitoring daily the management of pre- and post-marketing vigilance cases (all regulatory statuses) in line with the Case Management team and the Service provider (book-in, data entry, documentation, evaluation, quality control medical review and submission of the cases) to ensure compliance with regulatory requirements, with Safety Data Exchange Agreements and procedures in placeSelecting and managing service providers (draft of specifications, selection of the provider in line with legal and purchasing internal rules, draft of the service contract, quality of service monitoring)Setting up and monitoring the activities outsourced to the service providersEnsuring the implementation and follow-up of the literature surveillance process as well as the monitoring of the service provider in charge of this activityParticipating in impact analysis of regulatory intelligence regarding her/his scope of activitiesSetting-up of the SMP (safety management plan) prior study initiationContribution on the monitoring of Key performance indicatorsGeneral responsibilitiesCreating and maintaining quality documents related to her/his scope of activities and ensuring those quality documents are in line with regulatory requirementsPeriodically reporting on department activities to the direct line managerIdentifying potential risks in terms of organization and needs, proposing solutions and CAPAs as neededContributing to the preparation and monitoring inspections and audits by business partners on a Global Safety departmental level and in the regions allocated to the unitDevelopment of the team, including recruitment, annual appraisal, performance monitoring and developmentEnsuring follow-up of the allocated budgetDeveloping the team while promoting Servier Leadership Model, compliance and HR rules and best practicesProfile & ExperiencePharmacist, ScientificAt least 6 years of experience in the pharmaceutical industry in PV in an international environment with activities to capture vigilance casesKnowledge of PV information systems and IT project managementExcellent knowledge of global regulatory requirementsFluency in EnglishLeadership skills & aptitudesWe are committed to equal opportunities and talent development in all their diversity. If you identify with this offer, we invite you to meet us.Seniority levelMid-Senior levelEmployment typeFull-timeJob functionManagement and ManufacturingIndustries: Pharmaceutical Manufacturing #J-18808-Ljbffr
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Pharmacovigilance Case Processing Manager
il y a 2 jours
Saclay, Île-de-France Servier France Temps pleinDate de parution: 8 nov. 2025Ville: SaclayPays/Région: FRType de contrat: CDIN° offre: 9734Pharmacovigilance Case Processing Manager (F/M)Nous sommes un groupe pharmaceutique à dimension humaine, international et indépendant, gouverné par une Fondation. Notre modèle, singulier, fait notre fierté mais, surtout, nous permet de servir pleinement notre...
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Pharmacovigilance Case Processing Manager F
il y a 3 semaines
Saclay, France Servier Temps pleinMissions & Activities Within Global Safety Department, the PV Case Processing Manager reports to Case Management and Pharmacovigilance Systems Dir., leads a dedicated team and achieves the following Case management - Setting a robust case management process. - Monitoring daily the management of pre- and post-marketing vigilance cases (all regulatory...
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Pv Officer
il y a 10 heures
Saclay, France Excelya Temps plein**About the Job** Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand. This role is an exciting opportunity to contribute to a dynamic, ambitious team in Pharmacovigilance. You will play a...
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International PV Project Manager
il y a 2 semaines
Saclay, France Excelya Group Temps pleinJoin Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand. This role is an exciting opportunity to contribute to a dynamic, ambitious team in Global Safety. You will play a critical part in driving...
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International PV Project Manager
il y a 2 semaines
Saclay, France Excelya Temps pleinJoin Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.This role is an exciting opportunity to contribute to a dynamic, ambitious team in Global Safety. You will play a critical part in driving...
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International PV Project Manager
il y a 7 heures
Saclay, Île-de-France Excelya Temps pleinJoin Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.This role is an exciting opportunity to contribute to a dynamic, ambitious team in Global Safety. You will play a critical part in driving...
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Safety Database Administrator
il y a 1 jour
Saclay, France Excelya Temps pleinSafety Database Administrator Join Excelya's Pharmacovigilance team as a Safety Database Administrator. In this pivotal role, you will ensure the effective management and operation of our safety database, contributing to the overall quality and compliance of our pharmacovigilance activities. Why Join Us? At Excelya, we are committed to excellence in...
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Safety Database Administrator
il y a 2 jours
Saclay, Île-de-France EXCELYA Temps pleinHybridOperations, PV & SafetyFull timeSaclay, Île-de-France, FranceOVERVIEWDescriptionWhy Join Us?At Excelya, we are committed to excellence in healthcare, and we invite you to be part of our dedicated team where your expertise can make a significant impact.As a young, ambitious health company with over 900 talented professionals, we strive to be Europe's...
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Safety Database Administrator
il y a 2 jours
Saclay, Île-de-France Excelya Temps pleinWhy Join Us?At Excelya, we are committed to excellence in healthcare, and we invite you to be part of our dedicated team where your expertise can make a significant impact.As a young, ambitious health company with over 900 talented professionals, we strive to be Europe's leading mid-size CRO, delivering the best employee experience. Our integrated service...
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Safety Database Administrator
il y a 2 jours
Saclay, Île-de-France Excelya Temps pleinWhy Join Us?At Excelya, we are committed to excellence in healthcare, and we invite you to be part of our dedicated team where your expertise can make a significant impact.As a young, ambitious health company with over 900 talented professionals, we strive to be Europe's leading mid-size CRO, delivering the best employee experience. Our integrated service...
