Pharmacovigilance System Lead

2 weeks ago

Industrial Area, India YD Talent Solutions Full time

About Client:Our client brings together Pharmacovigilance expertise, third party system knowledge and Deep technology to develop well-defined solutions, which address challenges across Medical Affairs, Regulatory and Safety functions. Our client solutions free up responsible personnel within Pharma companies to execute their stated responsibilities while staying true to the laws of the land, and ultimately achieving a balance between compliance and managing business risks. Their solutions are agile, flexible, and scalable, developed using advanced technologies that enable them to serve large and small organizations, both in developed and emerging markets. Our client is committed to bringing focus to things that really matter for advancing patient outcomes. Their solutions are agile, flexible, and scalable, developed using advanced technologies that enable us to serve large and small organizations, both in developed and emerging markets.Position Overview:Position: Argus Configuration LeadLocation: Onsite, Noida, IndiaExperience: 6+ years - Should have good understanding of the Pharmacovigilance/ Health Care domain. - Should have excellent knowledge of Oracle Argus Safety or other PV/Safety systems. - Should have experience in installing/configuration/validation of Argus Safety and customizations. - Should have good knowledge of SQL, PL/SQL. - Should have experience in configuring reports in Argus Aggregate and Periodic reports. - Should have experience in Regulatory Standards like 21 CFR Part 11, ICH, GxP. - Should have experience in Argus Business and system configuration. - Should be able to provide technical architecture and design as per the user requirements. - Should have experience in performing System Integration and User Acceptance testing as part ofupgrade/ implementation projects. - Should have good understanding of regulations (EU, FDA, MFDS, NMPS, Mexico, Taiwan and Russia)

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