Sakayajeevitha Stephen

Senior QPPV Associate at Astellas Pharma Europe
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Contact Information
us****@****om
(386) 825-5501
Location
Amsterdam Area, Netherlands, NL
Skills

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Experience

  • Astellas Pharma Europe
    • United Kingdom
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Senior QPPV Associate
      • May 2014 - Present

  • ICTOM B.V.
    • Pharmaceutical Manufacturing
    • Jr. Project Manager
      • Apr 2012 - Jun 2013

      ICTOM B.V. is an independent academic research organization that is specialized in designing, organizing and completing clinical projects in the field of vascular medicine. The organization is established to ensure a scientific approach in clinical trials in cardiovascular medicine.Roles and Responsibilities undertaken: Index/ Outcome events ManagementReconciliation of eventsSubject retention/discontinuationSubject Final status data management

  • ICON plc
    • Ireland
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Drug Safety Associate
      • Jan 2008 - Jun 2011

      Proficiency in Serious Adverse Event (SAE) Processing, Lab review, Case Report Form (CRF) review, Pharmacovigilance databases and Regulatory submission. Knowledge on ICH-GCP Guidelines and Drug Safety guidelines from FDA, MHRA, DCGI and EU.

Education

  • Tamil Nadu Government Dental College
    -

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