Patient Safety ICSR Manager

Job Description

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.

Key Duties and 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

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:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Remote-Eligible role, you can choose to be designated as:
1. Remote: work remotely five days per week and come into the office on occasion - you're always welcome on-site; or select
2. Hybrid: work remotely up to two days per week; or select
3. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Remote

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com