Litty T.

Completed 7 years of experience in Pharmacovigilance (Drug Safety) in ICSR
Case intake, Case processing, Quality check
 Hands-on experience with the Oracle Argus safety database
 Performed ICSR processing and reporting of safety information including data entry of
safety information, the initial determination of seriousness and determining follow-up
activities, which can be spontaneous, literature and Non-interventional studies, solicited
case, Interventional studies, E2B cases, CIOMS cases, License partner cases
 Coordinated with triage for tracking of case reports and case duplication.
 Complete daily timesheets, providing an accurate record of time spent on activities.
 Full data entry including medical coding and safety narrative.
 Responsible for coding all medical history, events, drugs/procedures/indications and
laboratory tests according to the appropriate dictionary (E.g. MedDRA, Company
Product Dictionary, WHO-DD.
 Responsible for writing medically relevant safety narratives of cases and checking the
completeness and accuracy of the data entered in the various fields. Understanding and
application of good documentation.
 Follow up with clients regarding outstanding queries and reconciliation of discrepancies.
 Performed peer quality control of the cases for quality, consistency, accuracy and
completeness of information as entered into the safety database and consistent coding of
Adverse Event terms, medical history, Lab data, and product.
With a Master of Pharmacy (M. Pharm) degree, to undertake challenging and responsible
assignments in the field of Pharmacovigilance (Drug Safety) with continuous learning and to
serve to the best of my abilities and experience.