Remote-Eligible Global PV Compliance Lead

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

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.