Pharmacovigilance Associate
CurrentPreparation and review of aggregate reports (PADER and PSUR)Hands on experience with ArisG and ARGUS databasesPreparation and review of aggregate reports as per the Regulations and SOPs.Perform daily work in conjunction with Manager for aggregate reports generation and any other tasks relevant toPharmacovigilance department.Liaise with various teams within APCER/UK/US office and customers/clients in order to achieve required outcomes and meettimelinesGeneration and review of… Show more Preparation and review of aggregate reports (PADER and PSUR)Hands on experience with ArisG and ARGUS databasesPreparation and review of aggregate reports as per the Regulations and SOPs.Perform daily work in conjunction with Manager for aggregate reports generation and any other tasks relevant toPharmacovigilance department.Liaise with various teams within APCER/UK/US office and customers/clients in order to achieve required outcomes and meettimelinesGeneration and review of SOPs and WIsSupport to Signal detection team with the relevant data from aggregate reportsResponsible for generation of Line listings from databaseCompliance to project guidelinesExecution of Company Standard Operating ProceduresMaintain awareness of changes to/new regulations affecting pharmacovigilance activitiesTo carry out necessary administrative duties required for the jobOther duties as assigned by management.Build and maintain good relationships across functional units and company affiliatesTrain and mentor new employees in PSUR writing and relevant pharmacovigilance activities Show less
