Case Management Qa Vendor Associate Job in Amgen Inc

Join Amgen s Mission of Serving Patients

At Amgen, you ll be part of something bigger driven by our shared mission to serve patients with serious illnesses. Since 1980, we ve been pioneering biotech innovations, focusing on oncology, inflammation, general medicine, and rare disease.Join us to help make a lasting impact on patients lives while transforming your career.

Case Management QA Vendor Associate

What You Will Do:
As a Case Management QA Vendor Associate, you will play a vital role in ensuring the quality and compliance of global case intake and processing activities. You will oversee vendors, manage case quality, and ensure adherence to regulatory requirements while supporting inspections, audits, and continuous improvement initiatives.

Key Responsibilities:

• Monitor and ensure vendors deliver high-quality Individual Case Safety Reports (ICSRs) that meet global regulatory standards.
• Act as the US/EU local safety office and primary FDA/EMA point of contact for safety reporting.
• Provide training and resources to vendors to maintain compliance and quality.
• Perform quality control reviews, trend analysis, and generate reports on case quality.
• Manage vendor case processing timelines for adverse event intake, triage, and submission.
• Support inspections, audits, and CAPA (Corrective and Preventive Action) activities.
• Assist in Periodic Aggregate Safety Reports (PASR) processes and maintain a state of inspection readiness.
• Collaborate with local safety offices and attend vendor management meetings.
• Analyze QC trends and recommend improvements.
• Support onboarding and offboarding of vendor staff.

What We Expect of You

Basic Qualifications:

• Bachelor s degree with 3 years of related experience, or
• Associate s degree with 5 years of related experience, or
• High school diploma/GED with 7 years of related experience
• Previous experience in managing teams, projects, or resource allocation

Preferred Skills:

• Knowledge of global pharmacovigilance regulatory requirements
• Proficiency in safety case processing and experience with global safety databases
• Strong communication skills, attention to detail, and experience supporting audits/inspections
• Proficiency in Microsoft Word, Excel, PowerPoint, Project, and Outlook

What You Can Expect from Us

Amgen is committed to supporting your professional growth and well-being with a collaborative, science-driven culture and a competitive Total Rewards Plan aligned with industry standards.

Equal Opportunity

Amgen is an Equal Opportunity Employer and embraces diversity. We provide reasonable accommodations for individuals with disabilities throughout the application process.