• Job Description

  Req#: 26-00505
  Responsibilities:
  • Perform case processing activities (triage, data entry, report distribution) as required.
  • ssess, 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.
  • Perform CRO case QC activities, reconciliation etc. as required.
  • Work on highest priority or assigned cases using Workflow Management System, or as directed.
  • Support PV inspections and audits as identified, including interviews and provision of requested data.
  • Monitor vendor KPIs/KQIs as designated by Purdue and in compliance with company guidelines and policies.
  • Perform additional tasks as assigned. Work independently, assess matters, propose resolutions, and appropriately escalate internally within Purdue organization.
  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.
  • nalytical skills and attention to detail.
  • ccountability - takes ownership of deliverables.

• About the company

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