Job Description

SUMMARY:

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

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 Client)
• 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 Client 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 Client

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
• 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

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