Career Category
Medical Services
Job Description
Join Amgen’s Mission of Serving Patients
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with reliable illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

What you will do
Support interactions with business partners (license partners)



and vendors for all case intake and processing activities. Vendor oversight of all case intake and processing activities and case quality including analysis and reporting of trends in quality measures. Ensure vendor compliance with approved processes and training requirements. Submission of all individual case safety reports to FDA/EMA, business partners (license partners), and vendors. Act as US/EU local safety office and FDA/EMA point of contact for safety reporting. Provide audit & external inspection support.

Job Summary:
- Accountable for quality of device/combination product Individual Case Safety Reports (ICSR) processing globally for clinical trial and post-market cases.
- Ensure Vendors deliver high quality device/combination product cases through metric management and meet all worldwide regulatory authority requirements.
- Provide vendors with resources and training to perform their role.
- Responsible for ra

📌 Case Management – Specialist (Hyderabad)
🏢 AMGEN
📍 Hyderabad