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 Responsibilities:Set up and manage the local pharmacovigilance systemConduct local literature searchesManage local ICSR processesPerform 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 affiliates, service providers, and third partiesCoordinate closely with the global PV system and related departmentsMaintain and review pharmacovigilance proceduresSupport the Deputy in PV activities and replace them during absencesTake on additional tasks as needed, including project management and client contact rolesEducation and Experience:A university degree in Life Sciences is desirable but not essential. Several years of experience and profound knowledge in pharmacovigilance are required. Knowledge of relevant legislative and non-legislative guidelines is essential.Skills, Knowledge, and Abilities:Proven leadership, mentoring, and management skillsAbility to train and support junior colleaguesExperience managing small projectsAbility to manage internal and external relationshipsExcellent communication skills (written and verbal)Ability to communicate issues and propose solutions effectivelyGood presentation skillsFluent in English and Italian
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