Pharmalex is growing! As a result, we are looking for a PV Manager in Italy to lead projects. We seek a strong PV Specialist ready to step into an oversight role.Main ResponsibilitiesSet up and manage the local pharmacovigilance systemConduct local literature searchesManage local ICSRPerform PV intelligence screeningMaintain the local PSMFEstablish local organized data collectionManage local PVAAdapt and submit PSUR/RMP locallyDetect signals locallyImplement additional risk minimization measuresReview materials related to local post-authorization safetyParticipate in PV audits and inspectionsAttend project meetings as scheduledProvide monthly PV reports on the local PV system statusEnsure PV training for affiliate staff, service providers, and third partiesCoordinate with the global PV system and related departmentsMaintain and review pharmacovigilance proceduresCollaborate with the Deputy and inform them of PV activitiesEducation and ExperienceA university degree in Life Sciences is desirable but not essential. Several years of experience and profound knowledge in pharmacovigilance are required, along with expertise in relevant legislative guidelines.Skills, Knowledge, and AbilitiesLeadership, mentoring, and staff management skillsAbility to train and support colleaguesProject management skillsOperational relationship managementExcellent communication skills (written and verbal) in English and Italian
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