Job Description
Duties:
Drug Safety Associate at Purdue
Job Description
" Perform case processing activities (triage, data entry, report distribution) as
required.
" Assess, process, and data enter all AE case types to meet compliance
requirements.
" Perform triage on all case types to determine prioritization (if requested by
Purdue)
" Identify adverse events, seriousness, and listedness/labeledness for case
assessment; review additional incoming information to determine
reportability.
" Perform all appropriate coding reviews using MedDRA, WHO-DRUG, and
Company Product dictionaries.
" Own case narrative - create narrative text as required for medical
orientation.
" Determine follow-up requirements and request follow-up as appropriate (e-
mail, phone call, letter, etc.) to request additional information.
" Perform CRO case QC activit...
Drug Safety Associate at Purdue
Job Description
" Perform case processing activities (triage, data entry, report distribution) as
required.
" Assess, process, and data enter all AE case types to meet compliance
requirements.
" Perform triage on all case types to determine prioritization (if requested by
Purdue)
" Identify adverse events, seriousness, and listedness/labeledness for case
assessment; review additional incoming information to determine
reportability.
" Perform all appropriate coding reviews using MedDRA, WHO-DRUG, and
Company Product dictionaries.
" Own case narrative - create narrative text as required for medical
orientation.
" Determine follow-up requirements and request follow-up as appropriate (e-
mail, phone call, letter, etc.) to request additional information.
" Perform CRO case QC activit...