Enters information into PVG quality and tracking systems for receipt and tracking ICSR as required.
May assist in the preparation of the project plans such as Safety Management Plan.
May perform set-up, delivery and close-out of safety and pharmacovigilance projects.
Processes ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific
safety plans.
o Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report
ability.
o Enters data into safety database.
o Codes events, medical history, concomitant medications, and tests.
o Compiles complete narrative summaries.
o Assesses information to be queried and follows up until information is obtained and queries
are satisfactorily resolved.
o Participates in the generation of timely, consistent, and accurate reporting of expedited
reports in accordance with applicable regulatory requirements.
o Coordinates with data management staff concerning reconciliation of safety data between the
clinical and safety databases