Case Management QA Vendor Sr Associate
Location: India - Hyderabad
Work Location Type: On Site
Date Posted: Feb. 03, 2025
Category: Quality
Join Amgen’s Mission of Serving Patients
At Amgen, you are part of something bigger. Our shared mission—to serve patients living with serious illnesses—drives everything we do. Since 1980, we’ve pioneered biotechnology, fighting the world’s toughest diseases in four therapeutic areas: Oncology, Inflammation, General Medicine, and Rare Disease. Join us to make a lasting impact on patients’ lives.
Position Overview:
The Case Management QA Vendor Sr Associate plays a crucial role in managing and ensuring the quality and compliance of case intake and processing activities across clinical trial and post-market cases. The role supports vendor oversight, regulatory submissions, audit readiness, and compliance with global pharmacovigilance requirements.
Key Responsibilities:
Support interactions with business partners (license partners) and vendors for case intake and processing activities.
Oversee vendor compliance, quality measures, and approved processes/training requirements.
Ensure timely submission of Individual Case Safety Reports (ICSR) to FDA, EMA, business partners, and vendors.
Act as US/EU local safety office and FDA/EMA point of contact for safety reporting.
Provide audit and external inspection support.
Assist in assuring the quality of global ICSR processing for clinical trial and post-market cases.
Ensure vendors deliver high-quality cases through metric management and regulatory requirements.
Provide resources and training to vendors to perform their role effectively.
Analyze and communicate case Quality Control results.
Manage escalation of case-related issues from vendors.
Undertake activities delegated by the Qualified Person for Pharmacovigilance (QPPV) as detailed in the PV System Master File.
Maintain a state of inspection readiness.
Support Periodic Aggregate Safety Reports (PASR) processes and associated metrics throughout the product lifecycle.
Ensure vendor case processing timelines for AE intake, triage, and submission are met.
Perform retrospective quality assurance (QA) of vendor-processed cases.
Handle day-to-day vendor management issues.
Support on-boarding and off-boarding of vendor staff.
Attend management meetings with vendors.
Analyze QC trends and support generating, communicating, and archiving reports of QC findings.
Support audits of CAPAs and other ICSR quality-related actions/recommendations.
Perform case reviews and generate performance metrics (retro QA/case corrections).
Basic Qualifications:
Master’s degree and 3 years of directly related experience OR
Bachelor’s degree and 5 years of directly related experience OR
Associate’s degree and 10 years of directly related experience OR
High school diploma/GED and 12 years of directly related experience.
Previous experience directly managing teams, projects, programs, or directing resource allocation.
Preferred Skills:
Understanding of global regulatory requirements for pharmacovigilance.
Proficiency in safety case processing.
Expertise in case intake and processing within multiple global safety databases.
Experience in supporting inspections or internal audits.
Strong communication skills and attention to detail.
Proficiency in Microsoft Suite: Word, Excel, PowerPoint, Project, and Outlook.
What You Can Expect from Us:
Competitive and comprehensive Total Rewards Plans aligned with local industry standards.
A collaborative, innovative, and science-based culture that supports professional and personal growth.
Apply Now!
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