Case Management Specialist – Device Safety (Pharmacovigilance)
Job ID: R-236207
Location: Hyderabad, India (Onsite)
Category: Information Systems / Pharmacovigilance
Employment Type: Full Time
Company: Amgen
Job Overview
ThePharmaDaily.com is featuring a critical opportunity for a Case Management Specialist – Device Safety with Amgen in Hyderabad. This role is responsible for the global quality oversight of Individual Case Safety Reports (ICSRs) related to medical devices and combination products across clinical trial and post-marketing settings.
The position plays a key role in ensuring regulatory compliance with global health authorities including FDA and EMA, overseeing vendor performance, maintaining inspection readiness, and supporting pharmacovigilance quality systems. This is a strategic safety operations role within a global biotechnology organization.
Experience Level
Senior / Specialist Level
Experience Required:
Doctorate degree with minimum 4 years of Drug Safety or Life Sciences experience, OR
Master’s degree with minimum 7 years of Drug Safety or Life Sciences experience, OR
Bachelor’s degree with minimum 9 years of Drug Safety or Life Sciences experience.
Preferred Experience:
Pharmacovigilance or Quality experience in biotech, pharmaceutical, or medical device industry.
Experience with safety databases or corporate intake systems.
Prior audit and regulatory inspection support experience.
Key Responsibilities
Device & Combination Product Case Management
Ensure global quality and compliance of Individual Case Safety Reports (ICSRs) for device and combination products.
Oversee case intake and processing activities managed by vendors.
Ensure timely and compliant submission of ICSRs to FDA, EMA, license partners, and regulatory authorities.
Act as US/EU local safety office contact for regulatory safety reporting.
Vendor Oversight & Quality Management
Monitor vendor performance through quality metrics, trend analysis, and reporting.
Ensure vendors comply with approved processes, training requirements, and regulatory standards.
Identify and escalate case-related issues; implement corrective actions where necessary.
Regulatory Compliance & Inspection Readiness
Operate within the Pharmacovigilance Quality Management System (QMS).
Support audit and inspection readiness activities.
Perform delegated activities from the Qualified Person for Pharmacovigilance (QPPV) as defined in the PV System Master File.
Maintain documentation in accordance with Good Pharmacovigilance Practices (GVP) and Good Manufacturing Practices (GMP).
Safety Reporting & Aggregate Reporting Support
Support Periodic Aggregate Safety Reports (PASR) processes and related metrics.
Ensure accurate documentation of Product Complaints (PC), Adverse Events (AE), and Other Safety Findings (OSF).
Process & System Enhancement
Contribute to implementation of new safety intake systems, processes, and procedures.
Apply analytical skills to assess moderately complex case scenarios across multiple systems.
Develop solutions to technical or operational issues within defined SOP frameworks.
Educational Qualifications
Bachelor’s Degree in Life Sciences, Healthcare, Pharmacy, or related scientific discipline required.
Advanced degree (Master’s or Doctorate) preferred.
Required Skills and Competencies
Strong understanding of global regulatory requirements (GVP, GMP, FDA, EMA guidelines).
Experience in clinical development and post-marketing safety processes.
High case-level productivity with strong quality focus.
Excellent attention to detail and analytical problem-solving skills.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, Project).
Ability to work in matrixed, cross-functional environments.
Strong organizational and time management skills with ability to meet strict deadlines.
Why Consider This Role
Opportunity to work in global Device Safety and Pharmacovigilance operations.
Exposure to regulatory submissions and international health authority interactions.
Involvement in safety oversight for innovative biologics and combination products.
Career progression in global Drug Safety and Risk Management functions.
About Amgen
Amgen is a global biotechnology company focused on developing innovative therapies across Oncology, Inflammation, General Medicine, and Rare Diseases. Since 1980, the organization has been at the forefront of scientific advancement, serving millions of patients worldwide through research-driven innovation and a strong commitment to quality and compliance.
SEO Keywords
Device Safety Specialist Hyderabad, Pharmacovigilance Jobs India, ICSR Processing Careers, Drug Safety Specialist Amgen, Combination Product Safety Jobs, FDA EMA Safety Reporting, PV Quality Management Jobs 2026, Biotech Pharmacovigilance Careers.
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