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Literature Review Specialist

8-13 years
Not Disclosed
10 July 31, 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

 

Literature Review Specialist – Pharmacovigilance

Location: Hyderabad, India
Work Mode: On-site
Experience Required: 8–13 years
Category: Drug Safety / Pharmacovigilance
Job ID: R-219483


Job Summary

Amgen is looking for an experienced Literature Review Specialist to join its Global Pharmacovigilance Safety Team in Hyderabad, India. This role involves weekly surveillance of biomedical literature using bibliographic databases like Embase, Medline, and BIOSIS to support signal detection and ICSR identification across Amgen’s drug portfolio. You’ll ensure literature compliance, maintain global pharmacovigilance standards, and support audits and inspections while mentoring junior team members.


Key Responsibilities

  • Weekly review of literature for ICSRs and aggregate safety data

  • Identify articles requiring full-text access or translation

  • Evaluate citations for inclusion in signal detection or periodic reports

  • Perform quality checks on team literature reviews

  • Notify business partners about relevant safety literature

  • Order full-texts and request translations when needed

  • Assist with periodic report QC and audit support

  • Provide training and mentorship to junior safety reviewers

  • Recommend and support literature process improvement initiatives


Required Skills & Qualifications

  • 8–13 years of experience in pharmaceutical, biotech, or regulatory drug safety roles

  • Strong understanding of pharmacovigilance guidelines, including ICH-GCP and GVP

  • Direct experience using Embase, Medline, BIOSIS, and literature management systems

  • Familiarity with ICSR criteria and signal detection processes

  • Understanding of literature-based safety surveillance

  • Ability to review, flag, and interpret safety information from scientific sources

  • Exposure to AI-based tools and prompt design is a plus

  • Excellent organizational and communication skills


Perks & Benefits

  • Competitive salary with industry-aligned Total Rewards Plan

  • Inclusive, science-driven workplace culture

  • Professional growth through ongoing training and team collaboration

  • Work with a global leader in drug safety and biotechnology

  • Contribute to the health and safety of patients worldwide


Company Description

Amgen is a pioneering global biotechnology company committed to advancing therapies in Oncology, Inflammation, General Medicine, and Rare Diseases. With a strong focus on innovation and patient-centric science, Amgen’s Hyderabad site plays a critical role in global pharmacovigilance and safety surveillance operations.


Work Mode

On-site – Hyderabad, India


Call-to-Action

Advance your pharmacovigilance career with a global biotech leader. If you are passionate about patient safety and scientific excellence, apply today to join Amgen as a Literature Review Specialist. Begin your application now and help shape the future of drug safety.