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Medical Review Scientist

4+ years
Not Disclosed
10 April 9, 2025
Job Description
Job Type: Full Time Education: MD/DO 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:

Medical Review Scientist

 Job ID:

R-205810

 Location:

India – Hyderabad

 Work Location Type:

On Site

 Date Posted:

February 4, 2025

 Category:

Safety


 About Amgen

Amgen is a global leader in biotechnology focused on four key therapeutic areas: Oncology, Inflammation, General Medicine, and Rare Disease. Since 1980, Amgen has delivered innovative medicines to help millions of patients live longer, healthier lives. The organization values collaboration, innovation, and science-driven outcomes with a mission to serve patients worldwide.


 Role Summary

As a Medical Review Scientist, you will be responsible for conducting medical review of individual case safety reports (ICSRs) and supporting Amgen’s global pharmacovigilance operations. Your work ensures regulatory compliance and quality in safety surveillance activities.


 Responsibilities

  • Perform medical review of ICSRs (narratives, coding, expectedness, causality, seriousness)

  • Ensure regulatory compliance for global ICSR reporting

  • Maintain medical validity of reports and act as key contact for Case Management

  • Support Medical Safety Review Team (MSRT) and provide input to list of expected terms in auto label tool

  • Conduct ICSR escalation and case follow-up per SOPs

  • Perform reportability assessments for medical device and product complaint-related events

  • Contribute to quality assurance, training, and mentoring junior reviewers

  • Participate in Safety Assessment Teams (SAT) as needed

  • Assist with process improvements, SOP development, and internal/external audits

  • Serve as point of contact during Health Authority Inspections and maintain inspection readiness


 Basic Qualifications

  • MD/DO or international equivalent
    AND

  • 3 years of related drug safety experience

  • Knowledge of:

    • Amgen Medical Review and Case Management SOPs

    • Regulatory requirements in pharmacovigilance

    • Clinical trials and drug development

    • Amgen safety systems, databases, and medical coding

    • Clinical and post-marketing safety data capture


 Preferred Qualifications

  • MD/DO or international equivalent
    AND

  • 4 years of relevant work experience

  • Familiarity with Amgen’s therapeutic areas and products


 What You Can Expect from Amgen

  • A science-based, collaborative, and inclusive work environment

  • Competitive salary and Total Rewards Plans

  • Continuous learning and growth opportunities

  • A strong sense of mission to impact global patient health