Job Description

Job Description

Job Description

Primary Responsibilities

• 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
  • 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 follow-up as appropriate (e-mail, phone call, letter, etc.) to request additional information
• Support ICSR submissions and transmissions as needed.
• Perform CRO case QC activities, reconciliation etc as required.
• Work on highest priority or assigned cases using Workflow Management System, or as directed
• Participate in inspections and audits as identified, including interviews and provision of requested data
• Meet KPIs/KQIs as designated by Purdue and in compliance with company guidelines and policies
• Assist in writing late ICSR related deviations and CAPAs, upon request
• Perform additional tasks as assigned. Work independently, assess matters, propose resolutions, and appropriately escalate internally within Purdue organization

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