SENIOR PHARMACOVIGILANCE SPECIALIST

1 settimana fa

roma, Italia Pharma Point Srl A tempo pieno

Pharma Point, on behalf of a leading international consultancy company operating in the pharmaceutical sector, is seeking an experienced Senior Pharmacovigilance Specialist to be based in Italy.The selected professional will be responsible for the management and continuous improvement of the local pharmacovigilance system, ensuring compliance with both local and global requirements and maintaining close collaboration with cross-functional and global teams.Main Responsibilities :Establish and manage the local pharmacovigilance (PV) systemConduct local literature searches, ICSR management, and PV intelligence screeningMaintain local PSMF and manage local Organized Data Collection activitiesManage local Pharmacovigilance Agreements (PVAs)Adapt and submit PSURs and RMPs in accordance with local regulatory requirementsPerform signal detection and implement additional risk minimization measuresReview materials related to local post-authorization safety activitiesParticipate in PV-related audits and inspectionsProvide monthly PV reports on the status of the local PV systemEnsure PV training for affiliates, service providers, and third partiesCooperate closely with global PV systems and relevant departmentsReview, issue, and maintain local pharmacovigilance SOPs and working practicesAct as main contact for the Deputy PV activities and ensure adequate delegation during absencesRequirements :University degree in Life Sciences (preferred)Several years of experience and solid knowledge in pharmacovigilanceStrong understanding of pharmacovigilance legislation and guidelinesProven ability to lead, mentor, and train junior colleaguesStrong communication and presentation skills, with the ability to manage both internal and external relationships effectivelyBusiness fluency in English and ItalianLocation :Full-remoteEmployment Type :Permanent positionOffer :CCNL Chimico-Farmaceutico, Livello B, RAL €42,000 + MBO + Tickets Restaurant#J-18808-Ljbffr

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