Perform case processing activities including triage, data entry, and report distribution.
Assess, process, and enter data for all AE case types to meet compliance requirements.
Perform triage on all case types to determine prioritization as needed.
Identify adverse events, seriousness, and listedness/labeledness for case assessment; review additional incoming information to determine reportability.
Perform coding reviews using MedDRA, WHO-DRUG, and Company Product dictionaries.
Create narrative text as required for medical orientation.
Determine follow-up requirements and request additional information as appropriate.
Perform CRO case QC activities and reconciliation as required.