Namrata Rachuri

• Executed drug safety data management processes- a combination of
case intake, triage, Case entry, medical coding, narrative writing,
case follow-up (due diligence activity), and report preparation with
accountability for quality and timeliness of deliverables and
responsibility for process improvements.
• Reviewed adverse experiences (AEs) received from post marketing
sources for completeness and regulatory compliance.
• Assisted in compilation of regulatory submissions, i.e., Annual
Reports Periodic Safety Update Reports.
• Evaluate and assess the safety reports for completeness and scheduled
follow up requests accordingly (telephone, e-mail or facsimile).
• Review, assess, triage, process and report the
adverse event reports according to
applicable regulations, guidelines, SOPs, and
project requirements within the specified
timelines by meeting the quality standards.
• Coding of medical history, drugs and reported
adverse event terms in safety database using
medical dictionaries like Med DRA and WHO-
DRI
• Adverse events and its reporting standards.
• Practiced on Oracle Argus Safety 8.1 Database
- Intake, Data Entry, Case processing Med DRA coding, SAE narrative
writing.