Patient Safety ICSR Manager

General Summary: The Global Patient Safety Individual Case Safety Report (ICSR) Manager is responsible for performing Individual Case Safety Report (ICSR) processing activities, including case book-in, triage, case entry (structured field data-entry, event coding, narrative writing, and pursuit of follow-up information), finalization and reporting. The Global Patient Safety ICSR Manager works with a high degree of independence and is proficient at troubleshooting problems to create and execute improved internal procedures, and to ensure compliance with applicable regulatory requirements. This individual ensures that all work performed is in accordance with relevant regulatory guidelines. By virtue of their experience, the Global Patient Safety ICSR Manager is expected to provide guidance and leadership for ICSR processing and complete work in a resourceful, self-sufficient manner.

Performs workflow management activities, in addition to contributing in individual workflows Monitors GPS Inbox for receipt of safety information Performs initial ICSR book-in activities, including determination of a valid case as well as initial, follow-up, and duplicate information Archives ICSR documentation received through the GPS inbox per applicable procedures Reviews and interprets all new and follow-up safety information to determine the appropriate information to enter into the Global Safety Database Responsible for the management of all assigned ICSRs from receipt to ICSR closure, including follow-up requests Supports and/or executes timely reporting of ICSRs to Health Authorities/Regulatory Agencies and distribution of ICSRs to Vendors/Business Partners and other stakeholders as required Performs periodic Global Safety Database searches to support inquiries from stakeholders as required Performs case nullifications/deletions of ICSRs Provides feedback on quality and other periodic reviews Performs Business Partners and/or Vendor reconciliations and acts as a liaison as applicable Ensures that all international regulations are followed regarding PV procedures Assists in the creation of ad hoc safety reports for submission to relevant stakeholders May conduct presentations of safety issues, initiatives and projects Provides input on effectiveness of the safety management system and when applicable, provide suggestions for improvement of ICSR processing efficiency 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 Participates as a cross functional team member of Study Execution Teams Interfaces with study sites to ensure complete, accurate, and timely reporting of safety information Participates in Serious Adverse Event (SAE) Reconciliation activities Assists in developing and maintaining PV agreements and manages relationships with Vendors/Business Partners Mentors other Specialists and GPS staff Performs other duties as assigned Knowledge and Skills: Proficient in Argus Safety Embrace the application of AI solutions to simplify and build process efficiency Sound ability to communicate effectively in a matrix environment Ability to multi-task Solid written and oral communication skills Sound attention to detail Strong sense of responsibility and an ability to work autonomously, as well as act as a strong team player Displays ability to understand established procedures and communicate those procedures to others Education and Experience: 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 Pay Range: $121,600 - $182,400 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus