Job Description
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:
We’re enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Remote, Hybrid, or On-Site-Eligible role, you can choose to work:
1. On-Site and work 5 days per week with ad hoc flexibility;
2. Hybrid and work remotely up to two days per week; or select
3. Remote and work remotely with occasional travel to Vertex sites for business critical meetings/events.
#LI-AR1 #LI-Remote
Salary Range: $82,400- $123,600 USD annually
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
Pay Range:
$82,400 - $123,600
Disclosure Statement:
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
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