Pharmacovigilance Operations Associate

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 review 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 Activities

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 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

• Support audits and inspections

Knowledge and Skills

• 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 maintain high quality global literature review process

• Responsible for timely completion of review of weekly literature results

Education & Experience (Basic)

Master’s degree and 1 year of pharmaceutical, biotech or regulatory authority experience in a research and development setting

OR Bachelor’s degree and 1- 2 years of Literature screening/Review or relevant Safety experience

Education & Experience (Preferred)

Health Care/Lifescience Professional with minimum 2 - 3 years of relevant work experience including 1 to 2 years of experience in literature review

Knowledge of bibliographic databases and direct literature review experience preferred.