International PV Senior Specialist

Vertex Pharmaceuticals LLC; Boston (MA); Hybrid; USD 103,000 - 154,000; Full time

Benefits offered by this job

Remote-Eligible

Job summary

Vertex Pharmaceuticals LLC is seeking an International PV Senior Specialist to support build-out and management of the GPS International PV structure. You will work with independence to troubleshoot issues, improve procedures, and ensure compliance with global PV regulations, contributing to patient safety worldwide.

In this role you will oversee local RPPVs and key vendors, review regulatory intelligence, draft SOPs, and collaborate across geographies to support regulatory expansions.

Qualifications

• BS or PharmD/MSN with 3–5 years in PV or regulatory affairs.
• Proficiency with Microsoft Office applications.
• Ability to work autonomously in a matrix organization.

Responsibilities

• Ensure GPS procedures comply with global PV regulations.
• Oversee local Responsible Persons for Pharmacovigilance and key vendors.
• Review and track global PV regulatory intelligence.
• Develop and review PV agreements and contracts supporting local/regional PV requirements.
• Act as liaison to ensure Argus Global Safety Database configuration compliance based on PV Intelligence and expansion activities.
• Collaborate across geographic expansion initiatives and cross-functional teams.

Skills

Pharmacovigilance expertise

Regulatory compliance

Cross-functional collaboration

Strong communication

Problem solving

Education

Bachelor's degree in a relevant field

PharmD / MSN

Tools

MS Word

MS Excel

MS PowerPoint

Job description

Job Description General Summary: The International PV Senior Specialist is responsible for supporting build-out and management of the GPS International PV structure. The International PV Senior Specialist works with a degree of independence and supports troubleshooting problems and improving internal procedures, to ensure compliance with applicable regulatory requirements. This individual helps ensure that all work performed is in accordance with relevant regulatory guidelines. By virtue of their experience, the International PV Senior Specialist is expected to complete work in a resourceful, self-sufficient manner.

Key Duties and Responsibilities:

• Assists with ensuring that all GPS procedures are compliant with global PV regulations
• Supports oversight of local Responsible Persons for Pharmacovigilance (RPPVs) and key vendors
• Reviews, assesses, and tracks global PV regulatory intelligence
• Researches PV regulations and guidelines
• Develops and reviews PV agreements and contracts which support local and regional PV requirements
• 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 and projects
• Helps to identify key departmental needs and provides constructive input on solutions
• Represents GPS and Vertex regarding patient safety related matters as assigned
• 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-functional initiatives
• Ability to multi-task with sound attention to detail
• Solid written and oral communication skills
• Strong sense of responsibility and an ability to work autonomously, as well as acting as a strong team player
• Understands established procedures and communicates those procedures to others
• 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 regulatory requirements
• Ability to apply knowledge to new situations

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 work experience
• Proficiency in using Microsoft Office applications required (MS Word, MS Excel, MS PowerPoint)

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: $102,600 - $153,800

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: 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;
2. Hybrid: work remotely up to two days per week;
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 [e-mail]

Help Us Achieve Our Mission

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and conditions. The company has approved therapies for cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia, acute pain and acromegaly, and it continues to advance clinical and research programs in these areas. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including IgA nephropathy, neuropathic pain, APOL1-mediated kidney disease, primary membranous nephropathy, congenital adrenal hyperplasia, ACTH-dependent Cushing's syndrome, autosomal dominant polycystic kidney disease, type 1 diabetes, generalized myasthenia gravis, and myotonic dystrophy type 1. Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 16 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on LinkedIn, Facebook, Instagram, YouTube, and X

We believe our culture is one of Vertex’s greatest strengths and a key enabler of our ability to deliver transformative medicines for patients who need them. Rooted in innovation, purpose and collaboration, our culture empowers people to take smart risks, challenge conventional thinking and do their best work. The diversity of our people is central to that culture. By bringing together individuals with different backgrounds, experiences and perspectives, we foster an environment where new ideas thrive, better decisions are made and breakthrough innovation is possible. We are committed to creating a workplace where everyone feels valued, included and connected to our shared mission, because we know that our unique culture and the collective strength of our people are what set Vertex apart.