Manager, Drug Safety

Job Description

General Summary:

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
• Typically requires 4 years of experience or the equivalent combination of education and experience

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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.

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