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Case Management Qa Vendor Associate

3-7 years
Not Disclosed
10 Feb. 6, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Case Management QA Vendor Associate

📍 Location: India - Hyderabad
💼 Job ID: R-206995
🕒 Work Location Type: On-site
📅 Date Posted: Feb. 03, 2025
🗣 Category: Quality

Job Overview:

As a Case Management QA Vendor Associate at Amgen, you will support vendor oversight and ensure the quality of individual case safety reports (ICSRs). You’ll be responsible for ensuring that vendors meet quality standards, managing case intake and processing activities, and complying with global regulatory requirements.

Key Responsibilities:

  • Vendor Management: Oversee vendor performance in case intake, triage, and processing to meet regulatory requirements.
  • Case Quality Assurance: Perform retrospective quality assurance for vendor-processed cases and manage quality control findings.
  • Audit & Inspection Support: Assist with audit and external inspection support related to case management.
  • Training & Resources: Provide training and resources to vendors and ensure compliance with training requirements.
  • Data Analysis & Reporting: Analyze quality control trends and communicate findings. Generate and distribute performance metrics.
  • Documentation & Compliance: Ensure all case processing activities comply with safety reporting requirements for global authorities (e.g., FDA, EMA).

Qualifications:

  • Education:
    • Bachelor’s degree and 3 years of directly related experience, or
    • Associate’s degree and 5 years of directly related experience, or
    • High school diploma/GED and 7 years of directly related experience.
  • Preferred Skills:
    • Understanding of global pharmacovigilance regulations and safety case processing.
    • Expertise in safety databases and case intake/processing.
    • Experience supporting audits and inspections.
    • Strong communication skills and attention to detail.
    • Proficiency in Microsoft Suite (Word, Excel, PowerPoint, Project, Outlook).

What Amgen Offers:

  • Salary & Benefits: Competitive and comprehensive total rewards plans.
  • Culture: A collaborative, innovative environment focused on advancing science to serve patients.
  • Growth: Opportunities for professional and personal growth.

Compensation & Benefits:

  • Salary: Competitive, based on experience.
  • Benefits: Healthcare, retirement, and other industry-standard benefits.