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
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
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
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
As evident from the above, our minimum requirement for this position is a comprehensive understanding of:
Up-to-date knowledge of US and international PV regulations and best practices
Thinks globally and considers present and future impacts when making recommendations
Experience with PV vendor and business partner oversight and contract/agreement management
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