Pharmacovigilance Case Processing Manager
il y a 6 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 4 jours
Saclay, Île-de-France Servier France Temps pleinDate de parution: 5 janv. 2026Ville: 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 Database Administrator
il y a 7 jours
Saclay, France Excelya Temps pleinA mid-size CRO in healthcare is seeking a Safety Database Administrator to manage and maintain their pharmacovigilance database. The role requires expertise in regulatory compliance and safety data management, along with a strong understanding of clinical trial processes. Candidates should have at least 3 years' experience in a relevant role and be fluent in...
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Pharmacovigilance Data
il y a 7 jours
Saclay, France Excelya Temps pleinA healthcare-focused company is seeking a Safety Database Officer to manage functional database administration and support pharmacovigilance tasks. The ideal candidate will have a degree in Life Sciences and at least 3 years of experience in pharmacovigilance. Fluency in English is essential, and the role offers a chance to work in a dynamic environment...
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Test Case Designer
il y a 7 jours
Saclay, France Excelya Group Temps pleinAbout the Job Excelya is on the lookout for a skilled Test Case Designer to join our innovative and dynamic team. This role is crucial in ensuring the quality and reliability of our software products through rigorous testing and validation processes. As part of our company, you will have the opportunity to work with cutting‑edge technology and contribute...
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Test Case Designer
il y a 7 jours
Saclay, France Excelya Temps pleinAbout the JobExcelya is on the lookout for a skilled Test Case Designer to join our innovative and dynamic team. This role is crucial in ensuring the quality and reliability of our software products through rigorous testing and validation processes. As part of our company, you will have the opportunity to work with cutting-edge technology and contribute to...
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Test Case Designer
il y a 5 heures
Saclay, Île-de-France Excelya Temps pleinAbout the JobExcelya is on the lookout for a skilled Test Case Designer to join our innovative and dynamic team. This role is crucial in ensuring the quality and reliability of our software products through rigorous testing and validation processes. As part of our company, you will have the opportunity to work with cutting-edge technology and contribute to...
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Test Case Designer
il y a 5 heures
Saclay, Île-de-France Excelya Temps pleinAbout the JobExcelya is on the lookout for a skilled Test Case Designer to join our innovative and dynamic team. This role is crucial in ensuring the quality and reliability of our software products through rigorous testing and validation processes. As part of our company, you will have the opportunity to work with cutting-edge technology and contribute to...
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Safety Database Administrator
il y a 5 heures
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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Saclay, France IRT SystemX Temps pleinJoin IRT SystemX to imagine and design a safer, more efficient and more sustainable digital world. Working alongside our industrial and academic partners, our engineers and researchers address new uses cases that respond to major societal and technological challenges. Together, we are accelerating the digital transformation of industries, services and...
