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Literature Review Specialist
4 weeks ago
Key Responsibilities:
Literature Management Process -
- Perform review of literature results retrieved and imported into literature citation management system on a weekly basis and determine if minimum criteria for ICSR is met for marketed products
- Perform review of literature results to determine if article contains new aggregate safety information in support of the periodic report and/or signal detection
- Determine whether full text article needs to be ordered and order them if further information is needed to confirm if the citation meets criteria for ICSR or for signal detection
- Flag articles containing new aggregate safety information for TA Safety to perform secondary review
- Request Local Safety Officer to provide English translation if the article is not in English
- Notify business partner of articles received, if applicable
- Perform retrospective quality checks on the quality of the literature review performed by team
- Support audits and inspections
- Collaborate with Case Management and TA Safety on process improvement initiatives
- Proactively proposes and system and process improvement ideas
- Provide training and onboarding to junior staff
- Perform Quality checks on literature reviews performed by other staff
Periodic Reporting Process -
- May assist with quality control of periodic reporting activities as required.
- Extract list of citations for inclusion in periodic reports
Key Activities
- Responsible for routine review of literature articles as part of the global literature surveillance process
- Assist with quality control of periodic reporting activities
- Support audits and inspections by extracting requested citations from literature citation management system
Knowledge and Skills
- Knowledge of product profiles for products assignment
- Ability to identify literature articles containing ICSR criteria or aggregate safety findings supporting signal detection
- Ability to order full text articles where needed
- Ability to receive feedback from Case Management and TA Safety and optimize quality of literature review
- Demonstrate knowledge of global aspects of pharmacovigilance
- Strong knowledge of processes and global regulations for pharmacovigilance and literature surveillance
- Ability to effectively manage competing priorities and timelines
- Strong knowledge of literature citation management systems and platform used to configure search strategies
- Experience in use of AI and prompts would be useful
CONTRIBUTION:
- Ensures Amgen remains in compliance and maintains high quality global literature review process
- Responsible for the timely completion of review of weekly literature results
Education & Experience (Basic)
- 8-13 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting
- Knowledge of bibliographic databases and direct literature review experience (preferred)
