Amgen is inviting applications for the position of Case Management – Specialist (Device Safety) at its Hyderabad location. This is a senior-level pharmacovigilance role focused on device and combination product safety, regulatory compliance, and vendor oversight within a global biotech environment.
If you have strong experience in Drug Safety, Pharmacovigilance, ICSR processing, or medical device safety, this opportunity offers global exposure, regulatory authority interaction (FDA/EMA), and leadership in safety case management.
📍 Job Details
- Position: Case Management – Specialist (Device Safety)
- Location: Hyderabad, India
- Work Mode: On-Site
- Job ID: R-236207
- Category: Information Systems / Pharmacovigilance
🔬 Key Responsibilities
The Case Management Specialist – Device Safety will be accountable for the quality and compliance of Individual Case Safety Reports (ICSRs) for device and combination products.
Core Responsibilities:
- Ensure high-quality device/combination product ICSR processing
- Vendor oversight for case intake and case quality metrics
- Submission of safety reports to FDA, EMA, and global regulatory authorities
- Act as US/EU local safety office contact point
- Support audit and inspection readiness
- Ensure compliance with global Good Pharmacovigilance Practices (GVP) and Good Manufacturing Practices (GMP)
- Manage safety reporting timelines for clinical trial and post-market cases
- Support PASR (Periodic Aggregate Safety Reports) activities
- Implement SOP requirements for device safety cases
- Maintain inspection readiness under QPPV delegation
This role demands analytical skills, regulatory knowledge, and the ability to work within a Quality Management System (QMS).
🎓 Eligibility & Qualifications
Basic Qualification Criteria (Any One Required):
- Doctorate + 4 years Drug Safety/Life Sciences experience
- OR Master’s degree + 7 years Drug Safety/Life Sciences experience
- OR Bachelor’s degree + 9 years Drug Safety/Life Sciences experience
Preferred Qualifications:
- Experience in Pharmacovigilance or Quality in biotech/pharma/device industry
- Background in health sciences, pharmacy, or life sciences
- Experience with safety databases or intake systems
- Knowledge of global regulatory reporting standards (FDA, EMA)
- Familiarity with project management tools
- Strong case-level productivity and quality record
🧠 Required Skills
- Strong understanding of global pharmacovigilance regulations
- Experience in ICSR processing for device/combination products
- Vendor management and compliance oversight
- Attention to detail and regulatory accuracy
- Proficiency in Microsoft Office (Excel, Word, PowerPoint, Outlook)
- Ability to work in a matrix environment
💼 Why Join Amgen?
As a global biotech leader, Amgen offers:
- Competitive salary aligned with industry standards
- Comprehensive Total Rewards Plan
- Global exposure in device safety and pharmacovigilance
- Collaborative and science-driven culture
- Strong compliance-focused quality systems
📩 How to Apply
