Meta Title
Case Management QA Sr Associate – Hyderabad | Amgen
Meta Description
Join Amgen as a Case Management QA Sr Associate in Hyderabad. Ensure PV compliance and vendor quality. Apply now for an impactful pharma QA role.
Meta Keywords
pharmacovigilance jobs, QA associate Amgen, drug safety jobs India, Hyderabad pharma jobs, case processing, MedDRA, GVP, ICH-GCP, ICSR quality, PV audits
Case Management QA Vendor Sr Associate – Amgen (On-site, Hyderabad)
Job Summary
Amgen is seeking a skilled Case Management QA Vendor Senior Associate to join its Hyderabad-based Quality team. This role plays a key part in ensuring pharmacovigilance compliance through vendor oversight, safety case quality assurance, and regulatory submission support. Ideal for professionals experienced in case processing, MedDRA, GVP, ICSR quality control, and safety database management.
Key Responsibilities
Oversee vendor performance for adverse event intake, triage, and case submissions
Ensure adherence to global regulatory standards for case quality and processing timelines
Support FDA and EMA case submission processes and act as a point of contact for safety reporting
Perform retrospective QA and trend analysis on vendor-processed cases
Participate in audit and inspection support activities
Provide training resources to vendors and manage onboarding/offboarding
Generate performance metrics and QC reports
Track and support corrective and preventive actions (CAPAs)
Required Skills and Qualifications
Master’s degree with 3+ years of related experience
OR Bachelor’s with 5+ years
OR Associate’s with 10+ years
OR High School Diploma with 12+ years
Strong understanding of global PV requirements and regulatory compliance
Expertise in case intake, triage, and processing
Hands-on experience with safety databases and PV tools
Familiarity with MedDRA, GVP, ICH-GCP guidelines
Strong skills in Microsoft Office (Word, Excel, PowerPoint, Outlook)
Previous audit/inspection support experience
Attention to detail and strong written communication skills
Perks and Benefits
Competitive base salary and Total Rewards Plan aligned with industry standards
Inclusive, science-driven company culture with global career opportunities
Extensive training and career growth programs
Health, wellness, and insurance coverage
Opportunities to contribute to innovative drug safety practices
Company Description
Amgen is a global biotechnology leader dedicated to discovering, developing, and delivering innovative therapies that address serious medical conditions. With a strong presence in oncology, inflammation, general medicine, and rare diseases, Amgen combines science and commitment to improve patient lives.
Work Mode
On-site – Hyderabad, India
Compensation
While the base salary is not specified, Amgen offers a competitive and comprehensive Total Rewards Plan aligned with local pharmaceutical industry benchmarks.
Call to Action
If you're passionate about pharmacovigilance, quality systems, and patient safety, this is your opportunity to join a mission-driven global organization.
Apply now via Amgen Careers and help improve lives through science.
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