Literature Review Specialist

Career Category Safety Join Amgen s Mission of Serving Patients At Amgen if you feel like you re part of something bigger it s because you are Our shared mission to serve patients living with serious illnesses drives all that we do Since 1980 we ve helped pioneer the world of biotech in our fight against the world s toughest diseases With our focus on four therapeutic areas -Oncology Inflammation General Medicine and Rare Disease- we reach millions of patients each year As a member of the Amgen team you ll help make a lasting impact on the lives of patients as we research manufacture and deliver innovative medicines to help people live longer fuller happier lives Our award-winning culture is collaborative innovative and science based If you have a passion for challenges and the opportunities that lie within them you ll thrive as part of the Amgen team Join us and transform the lives of patients while transforming your career Group Purpose Group is accountable for global literature surveillance activities for all Amgen portfolio of products Responsible for performing the weekly review of literature articles for signal detection and identification of safety reports Job Summary This position is responsible for performing routine weekly reviews of literature articles retrieved from Embase Medline and BIOSIS which are the bibliographic databases used for Amgen s global literature surveillance The review supports signal detection for all Amgen portfolio of products and identification of individual case safety reports ICSRs for marketed products 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 What you can expect from us As we work to develop treatments that take care of others we also work to care for your professional and personal growth and well-being From our competitive benefits to our collaborative culture we ll support your journey every step of the way In addition to the base salary Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards Apply now for a career that defies imagination Objects in your future are closer than they appear Join us careers amgen com As an organization dedicated to improving the quality of life for people around the world Amgen fosters an inclusive environment of diverse ethical committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients Together we compete in the fight against serious disease Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race color religion sex sexual orientation gender identity national origin protected veteran status disability status or any other basis protected by applicable law We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process to perform essential job functions and to receive other benefits and privileges of employment Please contact us to request accommodation