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Job Description
The Patient Safety Individual Case Safety Report (ICSR) Manager is responsible for performing Individual Case Safety Report (ICSR) processing activities, including narrative writing, event coding, and pursuit of follow-up information. The 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 role ensures that all work performed is in accordance with relevant regulatory guidelines. Provides guidance to others for ICSR processing.
Key Duties and Responsibilities:
Reviews and interprets all new and follow-up safety information to determine the appropriate information to enter into the Global Safety Database
Manages the process of all assigned ICSRs from receipt to ICSR closure, including follow-up requests
Performs triage activities for incoming ICSRs
Ensures that all international regulations are followed regarding pharmacovigilance (PV) procedures
Interfaces with study sites to confirm complete, accurate, and timely reporting of safety information
Performs periodic Global Safety Database searches to support inquiries from stakeholders as required
Assists in the creation of ad-hoc safety reports for submission to relevant stakeholders
May assist more senior department members with signal detection activities, as needed
Assists in the training and development of other staff members in key processes and procedures
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
Participates in Serious Adverse Event (SAE) reconciliation activities
Assists in developing and maintaining PV agreements and manage relationships with Vendors/Business Partners
Identify, select, and manage relationships with Clinical Research Organizations for project management and related ICSR processing activities
Provide input on protocol development, as well as the development of Case Report Forms and Consent Forms
Mentors other Specialists and GPS staff
performs other duties as assigned
Knowledge and Skills:
Ability to work within a matrixed environment
Highly-skilled at multi-tasking with a keen attention to detail
Strong written and verbal communication skills to exchange sensitive/difficult information
Advanced understanding of established procedures and can communicate those procedures to others
Proficiency in Microsoft Office applications
Proficiency in safety database navigation including understanding of various medical coding applications
Comprehensive understanding of general PV concepts and practices
Education and Experience:
Bachelor's degree in a related field
4+ years of experience or the equivalent combination of education and experience
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.
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 Human Resources at ApplicationAssistance@vrtx.com.