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 (Individual Case Safety Reports)Perform PV intelligence screeningMaintain the local PSMF (Pharmacovigilance System Master File)Establish local organized data collectionManage local PVA (Pharmacovigilance Activities)Adapt and submit PSUR (Periodic Safety Update Reports) and RMP (Risk Management Plans)Detect signals locallyImplement additional risk minimization measuresReview materials related to local post-authorization safetyParticipate in PV-relevant audits and inspectionsAttend regular project meetingsProvide monthly PV reports on the local PV system statusEnsure PV training for affiliate employees, service providers, and third partiesCollaborate closely with the global PV system and related departmentsDevelop, review, and maintain pharmacovigilance proceduresSupport the Deputy in PV activities and provide relevant updatesTake on additional tasks and project management activities as neededEducation and Experience:A university degree in Life Sciences is desirable but not essential. Several years of experience and profound knowledge in pharmacovigilance are required. Expertise in relevant legislative and non-legislative PV guidelines is also necessary.Skills, Knowledge, and Abilities:Proven leadership, mentoring, and management skillsAbility to train and support junior colleaguesExperience managing small projects with defined scopeAbility to manage operational relationships with internal teams and clientsExcellent communication skills, both written and verbalStrong presentation skillsFluent in English and Italian
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