Literature Review Specialist Amgen Technology Private Limited

8.0 - 13.0 years

1 - 8 Lacs

Hyderabad, Telangana, India

On-site

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)

Posted 1 month ago

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