Pharmacovigilance Officer, Team Leader

4 settimane fa

Rome, Italia Altro A tempo pieno

Job DescriptionProviding support to other activities undertaken by the project team on behalf of the client and the companyPerforming activities in the scope of ICSR management unit within agreed extent and timeframe (including, but not limited to) :Processing Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelinesPerforming ICSR follow upSAE / SUSAR Management (unblinding, clinical trial reconciliation, protocol review, Safety Management Plan review)Reconciliation (clinical, partners)Personal data protectionProduct Quality Complaint handling and interaction with Quality AssuranceMedical Information interactionMedDRA and WHO codingDatabase Outputs and Reports (including data for monthly reporting to clients)Workflow & resource managementMentoring and training of new and more junior employees within the departmentSupport of PV processes related to the ICSR management within PrimeVigilance and also to clientsSupporting ICSR SMEs and contributing as one of ICSR SMEsPerforming activities in the scope of ICSR management unit within agreed extent and timeframeSupporting the RA & PV Network Department as needed, including acting as the LCPPV (Local Contact Person for Pharmacovigilance) for the specified country and taking on the role of PRLS (Person Responsible for Local Screening) for the designated language, as agreed with the line managerQualificationsLife science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilanceExtensive ICSR experience including mentoring and leading reportsExcellent communication (written and verbal) skillsOrganization skills, including attention to details and multitaskingDelegation skillsPlanning and time managementTechnical skillsTeam workingEnglish – fluent (spoken, written)Additional InformationWhy PrimeVigilance?We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.We offer :Training and career development opportunities internallyStrong emphasis on personal and professional growthFriendly, supportive working environmentOpportunity to work with colleagues based all over the world, with English as the company languageOur core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to joinQualityIntegrity & TrustDrive & PassionAgility & ResponsivenessBelongingCollaborative PartnershipsWe look forward to welcoming your application.#J-18808-Ljbffr

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