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Case Management Qa Vendor Sr Associate

3-12 years
Not Disclosed
10 Feb. 5, 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

Job Title: Case Management QA Vendor Senior Associate
Location: India - Hyderabad
Category: Quality
Job ID: R-206989
Work Location Type: On Site


About Amgen

Amgen is a global leader in biotechnology, driven by the mission to serve patients living with serious illnesses. The company has made significant advancements in Oncology, Inflammation, General Medicine, and Rare Diseases since its inception in 1980, positively impacting millions of lives. Amgen’s collaborative and innovative culture offers opportunities for employees to grow while transforming patient care.


Key Responsibilities

  • Vendor Oversight: Manage and oversee all case intake and processing activities performed by vendors, ensuring compliance with processes and training requirements.
  • Case Quality Management: Ensure that vendors deliver high-quality Individual Case Safety Reports (ICSRs), adhering to regulatory requirements globally.
  • Reporting & Analysis: Analyze and communicate the quality control (QC) results, identifying and escalating any case-related issues from vendors.
  • Audit & Inspection Support: Assist with audits and external inspections related to case management, including vendor liaison for support.
  • Training & Resources: Provide vendors with the necessary resources and training for optimal case processing.
  • Metrics & QC Trends: Monitor and report on QC trends, ensuring timely resolution of any deviations from processing standards.
  • Regulatory Compliance: Ensure vendor compliance with global regulatory requirements for pharmacovigilance.
  • Collaboration: Interact with other safety offices, support vendor on-boarding and off-boarding, and attend vendor management meetings.

Qualifications

  • Basic Qualifications:
    • Master’s degree with 3 years of directly related experience OR
    • Bachelor’s degree with 5 years of directly related experience OR
    • Associate’s degree with 10 years of directly related experience OR
    • High school diploma/GED with 12 years of directly related experience.
    • Experience managing teams, projects, or resources in a related field.
  • Preferred Skills:
    • Strong understanding of global pharmacovigilance regulatory requirements.
    • Proficiency in safety case processing and expertise in global safety databases.
    • Experience with internal audits or inspections.
    • Excellent communication skills and attention to detail.
    • Proficiency in Microsoft Suite (Word, Excel, PowerPoint, Project, Outlook).

What You Can Expect

  • Salary & Benefits: Competitive compensation and a comprehensive benefits package tailored to local industry standards.
  • Career Development: Opportunities for career advancement within a collaborative and supportive environment.