ABHISHEK POKHRIYAL

ICSR Case Processing- Clinical trial, Literature reports, Spontaneous Case Reports,

Regulatory authority reports etc.

➢ Literature screening via validated databases for screening of abstract and articles required

for the identification of potential ICSRs, PSURs and Signals.

➢ Performed Triage, Duplicate Search, Data Entry (General information, Patient

Information, Product Information, Lab Data), seriousness, causality, expectedness/

listedness and reporting.

➢ Identify and implement all clinical Standard-operating procedures in order to ensure GCP

guideline.

➢ Worked on Clinevo safety database.

➢ Performed adverse event coding from standardized medical coding such as MedDRA and

WHO drug dictionary.

➢ Generate concise, accurate, chronological and well written narrative writing.

➢ Identified case correction, follow up and created updates in safety database from medical

review.

➢ Ensured all cases that require expedited reporting are processed swiftly and appropriately

within required timeline.

➢ Identify and implement all clinical Standard-operating procedures in order to ensure GCP

guidelin