Case Management – Specialist (Device Safety)
Company: Amgen
Location: Hyderabad
Work Mode: On-site
Employment Type: Full-time
Experience Required: 7–9+ Years (depending on qualification)
Salary (India Estimate): ₹20 LPA – ₹35 LPA
Job Overview
Amgen is seeking a Case Management Specialist (Device Safety) responsible for ensuring the quality and compliance of Individual Case Safety Reports (ICSRs) for medical devices and combination products.
In this role, you will oversee global case intake and processing activities, manage vendor performance, and ensure compliance with regulatory authorities such as FDA and EMA. The position plays a key role in maintaining patient safety and regulatory reporting standards.
Key Responsibilities
Oversee device/combination product ICSR processing for both clinical trial and post-marketing cases.
Manage vendor performance and quality metrics related to safety case processing.
Ensure timely submission of safety reports to global regulatory authorities including FDA and EMA.
Act as a point of contact for US/EU safety offices and regulatory reporting.
Provide audit and inspection support for pharmacovigilance and case management activities.
Identify and resolve case-related quality or compliance issues.
Support Periodic Aggregate Safety Reports (PASR) and related metrics across the product lifecycle.
Ensure compliance with Quality Management System (QMS) and Standard Operating Procedures (SOPs).
Assist in implementing new safety intake systems, processes, and procedures.
Required Qualifications
Applicants should meet one of the following criteria:
Doctorate degree with 4+ years of Drug Safety or Life Sciences experience
Master’s degree with 7+ years of Drug Safety or Life Sciences experience
Bachelor’s degree with 9+ years of Drug Safety or Life Sciences experience
Preferred Experience
Experience in pharmacovigilance or quality roles within biotech, pharmaceutical, or medical device industries.
Experience with safety databases or corporate intake systems.
Familiarity with clinical development processes.
Knowledge of Good Pharmacovigilance Practices (GVP) and Good Manufacturing Practices (GMP).
Experience working in matrix or cross-functional team environments.
Ability to manage multiple projects and strict regulatory timelines.
Required Skills
Strong analytical and problem-solving abilities.
High attention to detail and data accuracy.
Experience managing ICSR processing and safety data quality.
Strong communication and stakeholder management skills.
Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook, Project).
Benefits
Employees at Amgen may receive:
Competitive salary and performance incentives
Comprehensive health insurance
Retirement and savings plans
Professional development and career growth opportunities
Inclusive, science-driven work environment
Global collaboration opportunities across biotech and pharmaceutical programs
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