Patient Safety ICSR Manager

Vertex Pharmaceuticals•Boston, MA

11d•Remote

About The Position

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.

Requirements

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
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

Responsibilities

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