Job Description

• Position performs adverse event processing and submission responsibilities supporting the Case Management function within Drug Safety Operations.

  Contract Duration:12 months

  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

    Education and Experience Requirements

  • Bachelor s degree (advanced degree preferred) in life science or healthcare (e.g. nursing, pharmacy)
  • Minimum 5 years of experience in a pharmaceutical/biopharmaceutical company
  • Minimum 3 years in Drug Safety Operations role;
  • Experience overseeing CRO teams of case processors preferred
  • US FDA pharmacovigilance inspection experience preferred

    Necessary Knowledge, Skills, and Abilities

  • Resource and workflow management (monitoring and assigning tasks)
  • Up-to-date knowledge of US and international PV regulations and best practices
  • MedDRA coding
  • Considers present and future impacts when making recommendations
  • Strong negotiation and problem-solving skills
  • Analytical skills and attention to detail
  • Accountability takes ownership of deliverables
• Summary of Work:

  Necessary Knowledge, Skills, and Abilities

  • Resource and workflow management (monitoring and assigning tasks)
  • Up-to-date knowledge of US and international PV regulations and best practices
  • MedDRA coding
  • Considers present and future impacts when making recommendations
  • Strong negotiation and problem-solving skills
  • Analytical skills and attention to detail
  • Accountability takes ownership of deliverables
  • 1 Year contract

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