Drug Safety Associate

Location: Stamford, CT (Fully remote and onsite required during Inspections)

Duration: 12 Months



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 Company)


• Identify adverse events, seriousness, and listedness / labeledness for case assessment; review additional incoming information to determine reportability


• Select the appropriate as reported causality and company causality


• Perform all appropriate coding 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 foll...