International PV Senior Specialist

Job Description

General Summary:

TheInternationalPVSeniorSpecialistisresponsibleforsupportingbuild-outandmanagementoftheGPS InternationalPVstructure.TheInternationalPVSeniorSpecialistworkswithadegreeofindependenceand supports troubleshootingproblems andimprovinginternal procedures, toensurecompliancewithapplicable regulatoryrequirements.Thisindividualhelpsensurethatallworkperformedisinaccordancewithrelevant regulatoryguidelines.Byvirtueoftheirexperience,the InternationalPVSeniorSpecialistisexpectedtocomplete work in a resourceful, self-sufficient manner.

Key Duties and Responsibilities:

• Assists with ensuring that all GPS procedures are compliant with global PVregulations
• Supports oversight of local Responsible Persons for Pharmacovigilance (RPPVs) and keyvendors
• Reviews, assesses, and tracks global PV regulatoryintelligence
• Researches PV regulations and guidelines
• Develops and reviews PV agreements and contracts which support local and regional PVrequirements
• Acts as business liaison to ensure Argus Global Safety Database configuration compliance based on PV Intelligence and geographic expansion activities
• Supports cross-functional geographic expansion initiatives
• Reviews and may be responsible for authoring Standard Operating Procedures (SOPs) and Work Instructions (WIs) with support from line management
• Conducts presentations of safety issues, initiatives andprojects
• Helps to identify key departmental needs and provides constructive input onsolutions
• Represents GPS and Vertex regarding patient safety related matters asassigned
  • Ensures prompt and accurate response to cross-functional teams and vendor questions on a continuous basis
  • Collaborates and continuously builds and fosters relationships cross-functionally and on a global scale with individuals of all levels
  • Be knowledgeable about and provide Pharmacovigilance information and guidance to cross-functional teams

Knowledge and Skills:

• Effectively operates in a matrix environment to support cross-functionalinitiatives
• Abilitytomulti-task withsoundattention todetail
• Solidwrittenandoralcommunicationskills
• Strong sense of responsibility and an ability to work autonomously, as well as acting as a strong teamplayer
• Understands established procedures and communicates those procedures toothers
• Ability to adapt and react to change in priorities and effectively manage workload with support from line management
• Maintains a current understanding of global PV regulatoryrequirements
• Ability to apply knowledge to newsituations

Education and Experience:

• B.S. (or equivalent degree) and 3-4 years of relevant work experience,or
• PharmD, M.S.N (or equivalent degree) and 3 – 5 years of relevant workexperience
• ProficiencyinusingMicrosoftOfficeapplicationsrequired(MSWord,MSExcel,MSPowerPoint)

At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.

Pay Range:

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.

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. 

#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 atApplicationAssistance@vrtx.com