DKSH

* Executive Regulatory Affairs & Pharmacovigilance

Posted: 10 hours ago

Job Description

Job SummaryTo be deputy person for Pharmacovigilance (PV) and Regulatory Affairs (RA) tasksManage and archive PV documents and RA/PV SOPsGeneral ResponsibilitiesPharmacovigilanceReceive, follow up Safety reporting casePrepare Safety reports for submission to Clients, relevant authorityAssist PV training and Client auditPerform internal and external reconciliation of Safety reportsPerform literature reviewManage and archive PV documents and SOPsOther tasks as assigned by line managerRegulatory AffairsSupport to prepare symposium dossiers (if required)Manage RA SOPsSupport admin part assigned by managers: PV payment, scan/ photocopy & archive reg. dossiers,…Other tasks assigned by managersFunctional Skills And KnowledgeAt least 3 year of experience in relevant field (safety experience includes actual experience processing Adverse events reports and experience with regulatory affairs tasks)Knowledge of relevant RA/PV regulationGood at English & Microsoft officesEducationDiploma/certification of Pharmacy or related disciplinesWhy It’s Great to Work at DKSHAt DKSH, we are driven by a purpose that goes beyond the ordinary: enriching people's lives. Through the products and services we provide, DKSH positively impacts millions of lives everyday. Join our team where entrepreneurship meets flexible work arrangements. Take the leap and start a journey where you can grow and make a difference!Learn more about working at DKSH: https://www.dksh.com/careers

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