Patient Safety ICSR Senior Specialist

Job Description

General Summary:

The Patient Safety Individual Case Safety Report (ICSR) Senior Specialist 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 Senior Specialist applies technical proficiency and attention to detail in ICSR processing as well as the ability to interpret and execute projects, under general guidance. This individual ensures that all work performed is in accordance with relevant regulatory guidelines.

Key Duties and Responsibilities:

• Reviews and interprets all new and follow-up ICSR source documentation to determine the appropriate information to enter into the Global Safety Database
• Manages the process for all assigned ICSRs from receipt to ICSR closure, including follow-up requests
• Ensures that all international regulations are followed in pharmacovigilance (PV) procedures
• Participates as a cross-functional team member of Study Execution Teams
• Interfaces with study sites to confirm complete, accurate and timely reporting of safety information
• Participates in Serious Adverse Event (SAE) Reconciliation activities
• Performs periodic Global Safety Database searches to support inquiries from stakeholders as required
• May assist 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
• May conduct presentations of safety issues, initiatives and projects
• Reviews and may be responsible for authoring Standard Operating Procedures (SOPs) and Working Instructions, under general guidance

Knowledge and Skills:

• Ability to work within a matrixed environment
• Ability to multi-task and strong attention to detail
• Solid written and verbal communication skills
• Demonstrates 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
• Solid understanding of general PV concepts and practices

Education and Experience:

• Bachelor's degree in a scientific or allied health field (or equivalent degree), PharmD or M.S.N.
• Typically requires 2 years of experience or the equivalent combination of education and 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.

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