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  • Sr. Pharmacovigilance Consultant

    Sajan Varughese

    24 years of experience 0 projects USA Research & Development
    EndocrinologyGIHematologyOncologyRare DiseaseRenal Safety & Pharmacovigilance AE/SAE ReportingArgus/OracleDrug SafetyDue DilligenceEndocrinologyGVPHealth CanadaHematologyInvestigational/pre-marketInvestigators BrochureMedDRAMedical codingMedical DeviceMedical surveillancePainPatient narrativesPDMAPharmacovigilanceRisk Based MonitoringRisk ManagementRisk Management PlanningSAE reconciliationSafety AnalyticsSafety due dilligenceSafety Management PlanSignal DetectionVendor oversight and managementVendor selection
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    Twenty-four years of experience in the Pharmaceutical Industry mostly in Global Pharmacovigilance and Risk Management department. Very deep understanding of functions within Research & Development (such as Clinical Development, Regulatory Affairs, and Medical Affairs) and outside of R&D (QA, Supply Chain, and Commercial). Within Pharmacovigilance, expert in Clinical Trial and Postmarketing Safety; Aggregate reports; global Risk Management Plans; PV Operations; Outsourcing (medical information and pharmacovigilance); and Vendor management. Longstanding expertise in risk management issues associated with drugs…