Career Category
SafetyJob Description
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
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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.