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.
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