Pharmacovigilance (Pv) Medical Manager

1 settimana fa

Firenze, Italia Menarini Group A tempo pieno

OverviewThe candidate will be part of the Global PV (GPV) Department, in particular, in the GPV IT-LDSU (Team responsible for the management of the PV activities of the Menarini Group Italian LDSUs and Marketing Authorization Holders, MAHs, of medicinal products registered in Italy), interacting with the other Units of the GPV Department as well as other Global and Local Departments.Main Activities & ResponsibilitiesThe chosen candidate will manage several PV activities such as:PV activities for one or more Italian Affiliates (e.g., as a LDSUM / Local Qualified Person for PV (LQPPV) for one or more Italian Affiliate or MAH and Deputy LDSUM/LQPPV for a different Italian Affiliate or a different MAH)PV Medical Assessor within GPV DepartmentPV activities for the GPV DepartmentCooperation with the GPV Director / European Qualified Person for PV (GPVD/EUQPPV)Cooperation with the other LDSUMs and DeputiesCooperation with the Local PV Quality AssuranceCooperation with the other GPV Units (Safety Operation Unit, SOU; Risk Evaluation Unit, REU; Quality Assurance Unit, QAU; Regulatory Compliance and Training Unit, RCTU)Medical AssessmentLocal and International Literature medical evaluationSignal Detection activitySafety Profile monitoringRegulatory enquiries management and medical evaluation of the Product InformationSafety Information managementHealth Authority safety enquiries managementHealth Authority website monitoringMaintenance of the Local PV system, according to the Local and Global procedures of Menarini Group and the Italian and European Regulations and GuidelinesManagement of the Local PV activities and maintenance of the concerning PSMFMaintenance of the Local Key Performance IndicatorsICSR managementFollow up activities with Health Care Professional (HCP) / ConsumerAggregate Reports activityPV Agreement activities and managementReconciliation with Partners, Providers and other Company DepartmentsJob RequirementsDegree in Medicine; Specialization, preferably in Pharmacology, Epidemiology, Medical Statistics, Internal Medicine,General Medicine (or equivalent branches, i.e. Cardiology, Neurology, Infectivology, etc.), Hygiene and Preventive Medicine (or equivalent branches).Previous work experience: as a physician or at least 1 year in PV, or PV MasterKnowledge of the main PV requirements and Guidelines (such as GVP)Advanced spoken and written of EnglishProactive, flexible as well as excellent analytical and writing skillsExcellent communication and interpersonal skillsStrong organizational, planning and problem solving skillsDIGITAL SKILLS:Operative System WindowsMicrosoft Office ExcelMicrosoft Office WordMicrosoft Office Power PointAdobe Acrobat ReaderMedDRA Dictionary

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