Senior Associate Literature Review

Literature Management Process

• Review weekly literature results imported into the literature citation management system to determine if they meet minimum criteria for Individual Case Safety Reports (ICSRs) for marketed products
• Assess literature articles to identify new aggregate safety information relevant to periodic reports or signal detection activities
• Order full-text articles when additional detail is required to determine reportability or support signal detection
• Flag relevant articles containing aggregate safety information for secondary review by Therapeutic Area (TA) Safety
• Coordinate with Local Safety Officers to obtain English translations of non-English articles
• Notify business partners upon receipt of relevant literature articles, if applicable
• Conduct retrospective quality checks of literature reviews performed by the team
• Support audit and inspection readiness
• Collaborate with Case Management and TA Safety for continuous process improvements
• Propose proactive system or process enhancement ideas

Periodic Reporting Process

• Assist with quality control activities related to periodic safety reporting, as needed
• Extract citations from literature databases for inclusion in periodic aggregate safety reports

Key Activities

• Execute weekly literature reviews in support of global literature surveillance
• Support audits and inspections by retrieving citations from the literature management system
• Assist with quality control tasks to ensure high standards in periodic reporting

Knowledge and Skills

• Familiarity with assigned product profiles to assess reportability of literature content
• Ability to identify articles with ICSR criteria or containing safety signals for escalation
• Proficient in full-text article retrieval and ordering procedures
• Open to feedback from TA Safety and Case Management and able to adjust review practices accordingly
• Demonstrated understanding of global pharmacovigilance regulations and surveillance standards
• Strong prioritization skills and ability to manage concurrent timelines
• Expertise in literature citation management systems and configuring literature search strategies
• Exposure to AI tools and prompts is considered an advantage

Contribution

• Ensures Amgen's continued compliance with global regulatory requirements through high-quality literature reviews
• Responsible for timely completion of weekly literature screening to support global safety processes

Education & Experience (Basic)

• 59 years of experience in pharmaceutical, biotech, or regulatory authority settings, ideally within R&D
• Direct experience in bibliographic databases and literature review is preferred