Amgen Hiring Case Management QA Vendor Associate in Hyderabad. Apply online for pharmacovigilance and quality assurance jobs in India.
About Amgen
Amgen is one of the world’s leading biotechnology companies, founded in 1980 with a mission to serve patients suffering from serious illnesses. With over four decades of scientific innovation, Amgen continues to pioneer life-changing medicines that address some of the world’s toughest diseases. The company operates across multiple therapeutic areas, including Oncology, Inflammation, General Medicine, and Rare Diseases, reaching millions of patients every year. Amgen Hiring Case Management QA Vendor Associate
At Amgen, employees are part of something much bigger than a job—they are part of a purpose-driven mission that combines cutting-edge science with a deep commitment to patient well-being. The company’s focus on research, manufacturing, and delivery of innovative medicines ensures that patients around the world live longer, healthier, and more fulfilling lives. Amgen Hiring Case Management QA Vendor Associate
Amgen’s collaborative and science-based culture empowers individuals to take on challenges, push boundaries, and innovate with purpose. For professionals looking to make an impact in global healthcare, Amgen offers a workplace where dedication, ethics, and innovation are valued above all else.
Position Overview
Job Title: Case Management QA Vendor Associate
Job ID: R-206995
Location: Hyderabad, India
Work Location Type: On-Site
Category: Quality
Date Posted: February 3, 2025
Amgen is currently hiring for the position of Case Management QA Vendor Associate at its Hyderabad office. This is a key role within Amgen’s Pharmacovigilance (PV) and Quality Management teams, focused on ensuring the highest quality in case management processes related to drug safety and regulatory compliance. Amgen Hiring Case Management QA Vendor Associate
As a Case Management QA Vendor Associate, you will be responsible for vendor oversight in case intake, processing activities, and quality assurance. You will support Amgen’s mission to deliver accurate, timely, and compliant safety reporting in alignment with global pharmacovigilance requirements. Amgen Hiring Case Management QA Vendor Associate
About the Role
In this role, you will work as part of Amgen’s Global Safety and Regulatory Operations team, providing oversight and quality assurance for vendor-managed case processing activities. The position requires a strong understanding of pharmacovigilance regulations, safety case management, and vendor compliance processes. Amgen Hiring Case Management QA Vendor Associate
You will be responsible for ensuring the accuracy and completeness of individual case safety reports (ICSRs), analyzing trends in case quality, and maintaining audit readiness. This role involves close collaboration with internal stakeholders, external vendors, and regulatory authorities to ensure that safety data is processed, reviewed, and submitted according to global standards. Amgen Hiring Case Management QA Vendor Associate
Key Responsibilities
As a Case Management QA Vendor Associate, your major responsibilities will include:
- Vendor Oversight and Quality Management
- Support interactions with vendors and business partners (license partners) for all case intake and processing activities.
- Oversee vendor performance, ensuring compliance with Amgen’s approved processes, quality standards, and training requirements.
- Monitor vendor case processing timelines for adverse event (AE) intake, triage, and submission to ensure regulatory deadlines are met.
- Quality Control and Assurance
- Conduct retrospective quality assurance reviews of vendor-processed cases.
- Analyze quality control (QC) results and report findings to management.
- Generate, communicate, and archive reports detailing QC findings and metrics.
- Support audits of Corrective and Preventive Actions (CAPAs) and follow-up measures to maintain high-quality standards.
- Regulatory Compliance and Safety Reporting
- Ensure submission of all individual case safety reports (ICSRs) to regulatory authorities such as FDA and EMA, as well as to business partners and vendors.
- Act as the local safety office point of contact for safety reporting in the US/EU.
- Assist in maintaining compliance with worldwide regulatory requirements for pharmacovigilance and drug safety.
- Training and Vendor Support
- Provide training, guidance, and resources to vendors to help them deliver high-quality outputs.
- Support onboarding and offboarding of vendor staff and ensure adherence to Amgen’s processes.
- Attend management meetings with vendors to discuss performance and quality improvements.
- Audit and Inspection Readiness
- Provide audit and external inspection support for case management activities.
- Liaise with vendors and local safety offices to prepare documentation for audits.
- Undertake tasks delegated by the Qualified Person for Pharmacovigilance (QPPV) as detailed in the Pharmacovigilance System Master File (PSMF).
- Continuous Improvement
- Analyze trends in QC results to identify opportunities for improvement.
- Support implementation of actions or recommendations to enhance case processing quality.
- Participate in ongoing reviews of SOPs and quality management frameworks to ensure global consistency.
- Additional Responsibilities
- Work within Amgen’s Quality Management System (QMS) framework, completing required training and adhering to controlled documentation.
- Support Periodic Aggregate Safety Report (PASR) processes and related quality metrics throughout the product lifecycle.
- Collaborate with cross-functional teams and local safety offices on global safety initiatives.
Qualifications and Experience
Basic Qualifications
Candidates must meet one of the following education and experience combinations: Amgen Hiring Case Management QA Vendor Associate
- Bachelor’s Degree and 3 years of directly related experience, OR
- Associate’s Degree and 5 years of directly related experience, OR
- High School Diploma / GED and 7 years of directly related experience, AND
- Proven experience in directly managing teams, projects, or resource allocation.
Preferred Skills and Experience
- Strong understanding of global pharmacovigilance regulations and safety reporting requirements.
- Proficiency in safety case processing, case intake, and ICSR submissions across multiple safety databases.
- Prior experience supporting regulatory inspections or internal audits.
- Ability to perform detailed QC reviews and identify data inconsistencies or process gaps.
- Strong communication skills, teamwork, and attention to detail.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Project, Outlook).
- Ability to analyze trends and prepare performance metrics or quality reports.
What You Can Expect from Amgen
At Amgen, employees are valued not just for their skills but for their potential and dedication to making a difference. The company offers a collaborative, inclusive, and dynamic work environment designed to help you succeed both professionally and personally. Amgen Hiring Case Management QA Vendor Associate
As an Amgen employee, you can expect:
- A competitive salary and comprehensive benefits package aligned with local industry standards.
- A supportive and inclusive workplace culture that encourages creativity, growth, and continuous learning.
- Opportunities to contribute to global scientific advancements that directly impact patient health.
- Access to world-class facilities, technologies, and professional development programs.
Amgen believes that when its employees thrive, so do patients. The company’s total rewards and career development structure ensure that every employee is empowered to grow within a culture that values collaboration, diversity, and integrity. Amgen Hiring Case Management QA Vendor Associate
Equal Opportunity Statement
Amgen is proud to be an Equal Opportunity Employer. The company considers all qualified applicants for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, protected veteran status, disability, or any other protected characteristic under applicable law. Amgen Hiring Case Management QA Vendor Associate
Amgen also ensures that individuals with disabilities are provided reasonable accommodation to participate in the application process, perform essential job functions, and enjoy equal access to benefits and privileges of employment. Amgen Hiring Case Management QA Vendor Associate
Work Location
- Location: Hyderabad, India
- Work Type: On-Site
- Job Category: Quality
- Job ID: R-206995
This position is based at Amgen’s Hyderabad office, where teams work collaboratively to support Amgen’s global operations in quality assurance, pharmacovigilance, and clinical safety. Amgen Hiring Case Management QA Vendor Associate
How to Apply
If you are an experienced professional in pharmacovigilance, safety case management, or quality assurance, and are looking to join a globally respected biotech company, this is your opportunity. Amgen Hiring Case Management QA Vendor Associate
To apply for the Case Management QA Vendor Associate position at Amgen, Hyderabad, follow these steps:
- Visit the official Amgen Careers Portal: https://careers.amgen.com
- In the search bar, enter Job ID: R-206995 or type “Case Management QA Vendor Associate – Hyderabad.”
- Review the full job description and eligibility criteria.
- Click on “Apply Now” to begin your online application.
- Create an account or log in to your existing Amgen Careers profile.
- Complete the application form, upload your resume, and submit your application.
Amgen encourages applicants to apply early to ensure timely consideration.
Conclusion
The Case Management QA Vendor Associate role at Amgen Hyderabad offers a rewarding opportunity for professionals seeking to advance their careers in pharmacovigilance, regulatory compliance, and quality management. This position is ideal for individuals with a passion for accuracy, data integrity, and patient safety. Amgen Hiring Case Management QA Vendor Associate
By joining Amgen, you’ll become part of a team that is not only shaping the future of biotechnology but also improving lives around the world. If you’re ready to take on a challenging and meaningful role with a global leader in biopharmaceutical innovation, apply now and start your journey with Amgen. Amgen Hiring Case Management QA Vendor Associate
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