Shylaja Thangella

Experience

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  GRATISOL LABS

  Oct 2021 - now

  Drug Safety Associate

  • Practical hands-on experience on Oracle Argus Safety Database - Data Entry, Case Processing, MedDRA coding, WHO Drug Coding, SAE narrative writing.• Experience in coding of adverse events with MedDRA and coding of drugs with WHO dictionaries.• Well versed with Pharmacovigilance concepts and Reporting guidelines including MedDRA coding and WHO-Drug Dictionary coding.• Assessment of case reports for seriousness, causality and expectedness.• Knowledge of Case Triage, Narrative writing, performing Labelling/ Listedness and Causality determination (Spontaneous & Literature cases).• Understanding of Drug Development Process including Drug safety and different Phases of Clinical Trials. Show less