Pharmalex is growing! As a result, we are looking for a PV Manager in Italy to lead projects. We are looking for a strong PV Specialist who is seeking a step up into an oversight role.Main responsibilities :Set up and manage the local pharmacovigilance systemLocal Literature SearchLocal ICSR ManagementLocal PSMF MaintenanceSetting up local Organized Data CollectionLocal PVA ManagementLocal adaptation and submission of PSUR / RMPImplementation of additional Risk Minimization MeasuresReviewing materials relating to local post-authorization safetyParticipate in PV-relevant audits and inspectionsAttend regular meetings according to project meeting scheduleProvide monthly PV report on status of local PV system in the country/iesEnsure PV training of affiliate employees, service providers, and Third PartiesClose cooperation with the global PV system of the client as well as related global and local departments and functionsIssue, review, and maintain pharmacovigilance procedures (e.g., Standard Operating Procedures, Working Practices) related to local tasks in connection with client proceduresClose cooperation with the respective Deputy and providing the Deputy with information on relevant current PV activitiesThe employee agrees to take over primary listed tasks and responsibilities in other service lines, project management activities as client contact point, and additional reasonable tasks that align with their abilities, qualification, and training, if requiredEducation and experience requiredUniversity degree in Life Science is desirable but not essentialSeveral years’ experience and profound knowledge in the field of pharmacovigilanceExpertise, experience, and knowledge regarding relevant legislative and non-legislative guidelines on pharmacovigilanceMinimum Skills, Knowledge and Ability RequirementsDemonstrable ability in leading, mentoring, managing, and motivating staff (team leads)Ability to train and support junior / new colleagues in daily activities; ability to lead small projects with a clearly defined scopeAbility to manage internal and external (client) relationships on operational / day-to-day working level as well as at the client's team lead levelGood communication skills (written and verbal); capability to communicate issues and propose appropriate solutions to decision makers. Good presentation skills.
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