Pharmalex is growing! As a result, we are looking for a PV Manager in Italy to lead projects. We are seeking a strong PV Specialist looking to step into an oversight role.Main responsibilities :Set up and manage the local pharmacovigilance systemConduct local literature searchesManage local ICSR processesMaintain local PSMFEstablish local organized data collectionManage local PVA activitiesAdapt and submit PSUR / RMP locallyImplement additional risk minimization measuresReview materials related to local post-authorization safetyParticipate in PV audits and inspectionsAttend regular project meetingsProvide monthly PV status reports for the local PV systemEnsure PV training for affiliate staff, service providers, and third partiesCollaborate closely with the global PV system and related departmentsMaintain pharmacovigilance procedures aligned with client standardsCoordinate with the Deputy and inform on PV activitiesDeputy assumes responsibilities during absencesBe willing to undertake additional tasks in other service lines, project management, or client interactions as neededEducation and experience requiredUniversity degree in Life Science preferred but not mandatorySeveral years of pharmacovigilance experienceKnowledge of relevant legislative and non-legislative PV guidelinesMinimum Skills, Knowledge, and AbilitiesProven leadership, mentoring, and team management skillsAbility to train and support junior colleagues and manage small projectsStrong operational relationship management skills with internal teams and clientsExcellent communication and presentation skills, both written and verbal
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