Drug Safety Operations Associate Job at Axelon Services Corporation, Stamford, CT

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  • Axelon Services Corporation
  • Stamford, CT

Job Description

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
Shift: 9.00am - 5.00PM Axelon Services Corporation

Job Tags

Contract work, Shift work,

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