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Associate Is - Icsr Distribution

0-3 years
Not Disclosed
10 May 1, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

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