Job Title: Case Management QA Vendor Associate
Location: Hyderabad, India (On-Site)
Date Posted: February 3, 2025
Category: Quality
About Amgen:
At Amgen, we believe in making a difference. Our mission to serve patients living with serious illnesses drives everything we do. Since 1980, we've been pioneering biotechnology to tackle the world’s toughest diseases. With a focus on four therapeutic areas—Oncology, Inflammation, General Medicine, and Rare Disease—we reach millions of patients each year. Join us to make a lasting impact while transforming your career.
Position Overview:
The Case Management QA Vendor Associate plays a crucial role in supporting vendor interactions, ensuring case intake and processing excellence, maintaining compliance with global safety requirements, and preparing for regulatory audits and inspections.
Key Responsibilities:
Vendor Oversight & Quality Assurance:
Manage interactions with business partners (license partners) and vendors for case intake and processing activities.
Oversee vendor compliance with approved processes, training requirements, and global regulatory standards.
Monitor vendor performance metrics to ensure timely and accurate processing of Individual Case Safety Reports (ICSRs) for clinical trial and post-market cases.
Provide vendors with resources, training, and feedback to ensure high-quality case management.
Case Processing & Safety Reporting:
Ensure vendors meet worldwide regulatory authority requirements, including FDA/EMA regulations.
Act as the US/EU local safety office and FDA/EMA point of contact for safety reporting.
Manage case intake, triage, and submission timelines to ensure regulatory compliance.
Perform retrospective quality assurance of vendor-processed cases.
Audit & Inspection Support:
Provide audit and external inspection support for case management-related activities.
Liaise with vendors to gather and present relevant documentation.
Undertake activities delegated by the Qualified Person for Pharmacovigilance (QPPV) and maintain a state of inspection readiness.
Support periodic aggregate safety report (PASR) processes and associated metrics.
Data Analysis & Continuous Improvement:
Analyze and communicate case Quality Control (QC) results and trends.
Generate and distribute performance metrics, supporting root cause analysis and corrective/preventive actions (CAPAs).
Participate in day-to-day vendor management and address operational issues.
Support onboarding and offboarding of vendor staff and attend vendor management meetings.
Basic Qualifications:
Education:
Bachelor’s degree with 3 years of directly related experience (OR)
Associate’s degree with 5 years of directly related experience (OR)
High school diploma / GED with 7 years of directly related experience.
Leadership Experience:
Previous experience directly managing teams, projects, programs, or directing the allocation of resources.
Preferred Qualifications:
In-depth understanding of global regulatory requirements for pharmacovigilance.
Proficiency in safety case processing and global safety databases.
Expertise in all aspects of case intake and processing.
Experience in supporting regulatory inspections or internal audits.
Strong communication skills and attention to detail.
Proficiency with Microsoft Office Suite: Word, Excel, PowerPoint, Project, Outlook.
What You Can Expect From Us:
Competitive base salary and comprehensive Total Rewards Plans aligned with local industry standards.
A collaborative and innovative culture that supports your personal and professional growth.
An opportunity to contribute to life-changing treatments and be part of a company making a global impact.
Apply Now
Defy imagination and take the next step in your career with Amgen. Join us and help transform the lives of patients around the world.
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