Job Description

General Summary:

The International Pharmacovigilance (PV) Specialist is responsible for supporting management of the GPS International PV structure. The International PV Specialist works with a moderate level of supervision and helps troubleshoot problems and improve internal procedures, to ensure compliance with applicable regulatory requirements.

Key Duties and Responsibilities:

• Assists with ensuring that all GPS procedures are compliant with global PV regulations
• Contributes to vendor oversight activities
• Supports the oversight of local Qualified Persons for Pharmacovigilance (QPPVs)
• Researches PV regulations and guidelines
• Reviews, assesses, and tracks global PV regulatory intelligence
• Reviews PV agreements which support local and regional PV requirements
• Works cross-functionally to plan and verify safety database configuration compliance based on PV intelligence and geographic expansion activities
• Performs compliance impact assessments as assigned
• Assists with production of presentations concerning safety issues, initiatives, and projects
• Represents GPS and Vertex regarding patient safety related matters as assigned
• Regularly responds to cross-functional teams’ and vendor questions
• Collaborates and builds/fosters relationships cross-functionally and on a global scale with individuals of all levels
• Provides PV information and guidance to cross- functional teams
• Performs other duties as assigned
• May also:
• Collect, analyze and utilize data and feedback / share information to identify opportunities to improve relationships cross-functionally, working effectively and lead business-wide improvements
• Liaise between GPS and members of International teams
• Communicate and coordinate activities and bridge alignment
• Triage and escalate patient safety related matters as appropriate
• Proactively raise awareness and promote GPS activities, policies and best practices
• Share information for innovative corporate improvement projects as endorsed

Knowledge and Skills:

• Effectively operates in a matrix environment to support cross-functional initiatives
• Ability to multi-task with sound attention to detail
• Solid written and verbal communication skills
• Ability to work under moderate supervision, as well as in a team setting
• Understands established procedures
• Ability to adapt and react to change in priorities and effectively manage workload with support from line management
• Basic understanding of global PV regulatory requirements
• Proficiency in using Microsoft Office applications required (Word, Excel, and PowerPoint)

Education and Experience:

• Bachelor's degree (or equivalent degree)
• Typically requires 1 to 3 years of relevant work experience

Pay Range:

$82,400 - $123,600

Disclosure Statement:

Flex Designation:

Remote-Eligible

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