Literature Review Specialist

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 -

Key Activities

Knowledge and Skills

CONTRIBUTION :

Education & Experience (Basic)

Skills Required

Pharmaceutical, Biotech