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Senior Associate Literature Review
ConfidentialHyderabad / Secunderabad, Telangana30+ days ago
Job descriptionAssist with quality control activities related to periodic safety reporting, as needed Extract citations from literature databases for inclusion in periodic aggregate safety reports 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 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 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 5–9 years of experience in pharmaceutical, biotech, or regulatory authority settings, ideally within R&D Direct experience in bibliographic databases and literature review is preferred
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
Key Activities
Knowledge and Skills
Contribution
Education & Experience (Basic)
Skills Required
literature review
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Senior Associate • Hyderabad / Secunderabad, Telangana