Senior Associate Literature Review
Location: Hyderabad, India
Job ID: R-219500
Posted On: June 30, 2025
Work Type: On-Site | Full-Time
Category: Safety
About Amgen:
Amgen is a biotechnology pioneer focused on using science and innovation to fight the world’s toughest diseases. With therapeutic expertise in Oncology, Inflammation, General Medicine, and Rare Disease, Amgen reaches millions of patients worldwide. Be part of a mission-driven team committed to making a lasting difference in human health.
Role Overview:
As a Senior Associate Literature Review, you will be a vital part of the Global Literature Surveillance team responsible for reviewing bibliographic databases (e.g., Embase, Medline, BIOSIS) to identify safety signals and individual case safety reports (ICSRs) for Amgen’s portfolio. Your work will ensure regulatory compliance, high-quality safety data, and timely reporting.
Key Responsibilities:
Literature Surveillance:
Conduct weekly reviews of literature retrieved from global databases.
Identify articles that meet minimum criteria for ICSRs or contribute to safety signal detection.
Flag articles with new aggregate safety information for therapeutic area (TA) safety review.
Order full-text articles and arrange English translations when necessary.
Notify business partners of critical article findings and maintain communication flow.
Quality Assurance & Compliance:
Perform retrospective quality checks on literature review outcomes.
Collaborate with Case Management and TA Safety teams to enhance review quality.
Support audits, inspections, and compliance readiness activities.
Periodic Safety Reporting:
Assist in extracting citation lists for inclusion in periodic safety reports (e.g., PBRER, DSUR).
Conduct quality control reviews related to periodic reporting tasks.
Required Knowledge & Skills:
Strong understanding of pharmacovigilance regulations and literature surveillance standards.
Familiarity with bibliographic databases (e.g., Embase, Medline) and literature citation management systems.
Ability to identify ICSRs and aggregate safety trends within literature.
Experience managing timelines and priorities in a compliance-focused environment.
Exposure to AI tools and search optimization using prompts is a plus.
Basic Qualifications & Experience:
Education: Bachelor’s or Master’s in Life Sciences, Pharmacy, or related field.
Experience: 5–9 years in pharmaceutical, biotech, or regulatory authority roles, ideally in a research & development or safety-focused setting.
Preferred: Direct experience in literature review and use of bibliographic databases.
Estimated Salary: ₹10–16 LPA (based on experience and industry benchmarks)
Gujarat :
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Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Frank Scottile Blvd |Missouri :
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Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
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Auckland |New Zealand :
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Barcelona |Madrid :
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Croatia |Zagreb :
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Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Rabigh | Jeddah | Najran | King Abdullah Economic City | Riyadh | Khulais |Kuala Lumpur :
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Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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