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Senior Associate Literature Review

5-9 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

 

Senior Associate – Literature Review

Location: Hyderabad, India
Work Mode: On-site
Experience: 5–9 years
Job ID: R-219500


Job Summary

Amgen is hiring a Senior Associate – Literature Review in Hyderabad to support its Global Safety team. In this critical pharmacovigilance role, you will review scientific literature from Medline, Embase, and BIOSIS to identify individual case safety reports (ICSRs) and aggregate safety signals. This position ensures compliance with regulatory surveillance processes and contributes to the safety evaluation of Amgen’s global product portfolio.


Key Responsibilities

  • Weekly review of literature citations to identify ICSRs and aggregate safety data.

  • Determine if articles meet minimum ICSR criteria for marketed products.

  • Flag articles with new safety data for secondary review by Therapeutic Area (TA) Safety teams.

  • Order full-text articles when needed and request English translations if applicable.

  • Notify business partners of relevant citations.

  • Conduct retrospective quality checks of literature reviews.

  • Collaborate with Case Management and TA Safety for process improvement.

  • Assist with periodic safety report QC activities.

  • Extract relevant citations for inclusion in regulatory safety reports.

  • Support audits and inspections.


Required Skills & Qualifications

  • 5–9 years of experience in pharmaceutical, biotech, or regulatory authority settings.

  • Bachelor’s or Master’s degree in life sciences or related fields.

  • Strong knowledge of pharmacovigilance regulations and global safety processes.

  • Experience using bibliographic databases (e.g., Medline, Embase, BIOSIS).

  • Proficiency in literature citation management systems.

  • Ability to identify articles containing ICSRs or signal detection data.

  • Experience in AI-driven literature tools is a plus.

  • Strong organizational, communication, and prioritization skills.


Perks & Benefits

  • Competitive base salary and total rewards package.

  • Collaborative, ethical, and science-driven work environment.

  • Opportunities for professional development in global drug safety.

  • Work with one of the world’s leading biotech companies.

  • Inclusive culture focused on career growth and work-life balance.


Company Description

Amgen is a global biotechnology leader committed to advancing innovative treatments in Oncology, Inflammation, General Medicine, and Rare Diseases. Amgen supports millions of patients worldwide and upholds the highest ethical standards in safety, science, and compliance. The Hyderabad site plays a key role in global pharmacovigilance operations.


Call-to-Action

Be part of a mission that truly matters. Apply now to join Amgen as a Senior Associate in Literature Review and make an impact in global patient safety. Start your application today and take the next step in your pharmacovigilance career.