Pharmacovigilance Operations Associate

Job Description:

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

Qualification & Experience

• 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