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Sr Global Patient Safety ICSR Manager


The Global Patient Safety (GPS) Individual Case Safety Report (ICSR) Manager is responsible for Vendor Management, and will act as Quality Lead providing oversight of both internal and vendor sites


•Key role in managing vendor sites
•Experienced in all ICSR workflow steps, including intake, data entry, narrative writing, case finalization and regulatory reporting
•Highly skilled in using the Argus database and good understanding of data-entry conventions
•Work with a high degree of independence
•Ensure compliance with applicable regulatory requirements and guidelines
•Sound decision making skills
•Solid written and oral communication skills

Key Responsibilities
•Provide comprehensive oversight on ICSR quality, specifically oversight on vendor case quality in each workflow step
•Thorough understanding of DEGs/SOPs/WIs to be able to provide oversight of ICSR quality
•Routine review of QST case quality listing, aggregate duplicate ICSR search listing and deleted/invalid case listings
•Devise and implement innovative methods to ensure that ICSR quality is improved and maintained internally as well as at vendor site/s
•Provide, support and implement proper training/corrective actions for observed quality issues
•Present formal quality and compliance metrics on a regular basis to ICSR management and team
•Serve as ICSR Workflow Manager to prioritize cases appropriately in the workflow, working closely with ICSR, safety physicians and vendor(s) to ensure all compliance and KPI targets are met
•Support case processing, as and when needed
•Ensures that all international regulations are followed regarding PV procedures. May conduct presentations of safety issues, initiatives and projects
•Reviews and may be responsible for authoring Standard Operating Procedures (SOPs) and Working Instructions, with minimal supervision
•Helps to identify key departmental needs and provides constructive input on solutions, including suggestions for improving ICSR process efficiencies.
•May assist in developing and maintaining PV agreements and managing relationships with Vendors/Business Partners
•Performs other duties as assigned

•B.S. (or equivalent degree) and 4 - 5 years of relevant work experience, or
•PharmD, M.S.N (or equivalent degree) and 3 - 5 years of relevant work experience
•Excellent project management skills with the ability to align internal and external resources
•Vendor management experience preferred

TSP Career Page Category Clinical and Healthcare

Sr Global Patient Safety ICSR Manager

Boston, MA
Full Time

Published on 06/25/2020