Job Title: Associate IS – ICSR Distribution
Location: India – Hyderabad (On Site)
Job ID: R-206432
Date Posted: February 4, 2025
Category: Safety
Company: Amgen
Job Summary
Amgen is seeking an Associate IS professional to support and optimize adverse event data processing across its safety systems. This role is ideal for early-career professionals in Life Sciences, Biotechnology, Pharmacology, or Information Systems who want to gain hands-on experience in pharmacovigilance technology operations. The position involves system issue resolution, process optimization, testing, reporting, and stakeholder collaboration within global regulatory and IT environments.
Key Responsibilities
Monitor and troubleshoot daily data processes for case transmissions and file delays
Resolve reconciliation issues and collaborate across internal and vendor teams
Maintain documentation of recurring issues and propose process enhancements
Develop dashboards/reports to monitor system performance and file flows
Perform system testing, regression testing, and automation of test cases
Ensure adherence to Key Control Indicators (KCI) and regulatory standards
Support software patches, system upgrades, and validate changes
Basic Qualifications
Bachelor’s degree with 0–3 years’ experience in Life Science/Biotech/Pharmacology/Information Systems
Diploma with 4–7 years of relevant experience
Preferred Qualifications
Experience with SQL and database queries
Familiarity with API integration tools (e.g., MuleSoft)
Knowledge of software testing lifecycle (STLC) and SDLC
Understanding of ITIL practices and regulatory compliance (e.g., 21 CFR Part 11)
Experience with reporting tools like Tableau
Excellent written and verbal communication skills
Fast learning ability with strong analytical and problem-solving skills
Why Join Amgen
Work on cutting-edge pharmacovigilance platforms
Collaborate globally and grow technical skills in a regulated industry
Competitive benefits and inclusive workplace culture
How to Apply
Visit: careers.amgen.com
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