Ajay Francis Christopher
Baba Farid University of Health Sciences, India
Biography
Ajay Francis Christopher, MSc (Molecular Biology & Biochemistry from Guru Nanak Dev University, India) served as PV Scientist, Senior Quality PV Scientist, Trainer cum Mentor and Subject Matter Expert-QAPV for Blue Chip pharmaceutical companies at premier CRO in India. He has over 12 years of experience in Clinical Research and Development and has one Young Scientist Award and various appreciation awards to his credit. He has coded over 5000 ICSRs (SUSAR, serious, non-serious reports) and reviewed over 3000 ICSRs, narratives and SSUR. He successfully led various international projects (global transition in narrative writing for regulatory submission, customization and validation of Oracle Argus Safety 5.0.2, etc).
Abstract
Abstract : Handling and processing safety reports from clinical trials and spontaneous origin
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