Integrated Signal Management (ISM) Engineer
Location: Hyderabad, India
Job ID: R-219501
Posted On: June 30, 2025
Work Type: On-Site | Full-Time
Category: Safety
About Amgen:
Amgen is a global biotechnology leader dedicated to serving patients with serious illnesses through cutting-edge science and innovation. Since 1980, Amgen has delivered life-changing therapies across therapeutic areas including Oncology, Inflammation, General Medicine, and Rare Disease. Join a mission-driven team that impacts millions of lives while advancing your career.
Position Summary:
As an ISM Engineer within the Post Market Surveillance & Trending group, you will play a critical role in monitoring product complaints, adverse events, and post-market product quality data. You will contribute to the integrated safety surveillance of Amgen’s combination products, medical devices, and diagnostics through data analysis, trending, and cross-functional collaboration. The role supports regulatory compliance, continuous improvement, and innovation through the use of AI/ML and automation technologies.
Key Responsibilities:
Surveillance & Trending:
Perform statistical deep-dive trending of product complaints and excursion analysis.
Analyze adverse events and complaint data for safety signals.
Prepare and interpret surveillance metrics for internal forums and regulatory responses.
Cross-Functional Collaboration:
Partner with Quality, Product Engineering, and Safety teams to assess risk and product performance.
Contribute to improvements in design, manufacturing, and safety surveillance processes.
Regulatory & Audit Support:
Provide ad-hoc data pulls and analysis for regulatory inquiries.
Support audits and inspections by verifying data and ensuring completeness.
Innovation & Technology:
Explore AI/ML tools and automation for enhancing post-market surveillance.
Identify opportunities for improving trending methodologies and process efficiency.
Required Qualifications:
Education: Degree in Engineering or Life Sciences
Experience: 5–9 years in quality and/or manufacturing within the biotech/pharma industry
Specialized Knowledge:
2+ years in complaints trending for Class II/III medical devices or combination products
Strong experience in data querying and visualization tools (e.g., Tableau, Power BI, or Python)
Familiarity with adverse events and complaint intake/processing workflows
Preferred Qualifications:
Experience with mechanical/electromechanical medical devices
Knowledge of device safety monitoring regulations and GxP standards
Experience in statistical trending methodology (preferably complaints)
Proficient in data analysis and cross-dataset correlation
Strong skills in presentation, team collaboration, and communication
Estimated Salary: ₹18–26 LPA (based on experience and industry benchmarks)
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