Associate Director, Global Patient Safety (GPS) Individual Case Safety Report (ICSR) Therapeutic Area (TA) Lead

Location: Boston, MA, United States. Remote-eligible with a choice of remote, hybrid, or on-site work under the Flex @ Vertex program.

Salary: $164,000–$246,000 per year, plus potential annual bonus and equity awards.

Company

Vertex is a global biotechnology company focused on scientific innovation and patient outcomes.

What you will do

• Lead therapeutic-area ICSR operations and oversee global case processing and reporting.
• Ensure adherence to global pharmacovigilance regulations and harmonize processes across therapeutic areas.
• Manage external PV partners and vendors, including KPI development, performance monitoring, and quality oversight.
• Develop innovative ICSR practices, including automation and artificial intelligence implementation.
• Mentor staff on pre- and post-marketing PV, clinical trial cases, spontaneous cases, and timely case delivery.
• Support audits, inspections, health authority inquiries, cross-functional initiatives, and operational quality improvements.

Requirements

• B.S. or equivalent degree in life sciences, or an allied health professional degree.
• 8+ years of direct clinical and post-marketing pharmacovigilance experience.
• 3–5 years of direct external partner, vendor, or outsourcing management experience.
• Hands-on experience with all operational aspects of ICSR processing and reporting.
• Strong project management, communication, analytical, and stakeholder-management skills.
• Ability to work autonomously, manage a fast-paced environment, and evaluate procedural gaps.

Nice to have

• Line management experience.

Culture & Benefits

• Choice of remote work five days per week with occasional office visits, hybrid work with up to two remote days per week, or on-site work with ad hoc flexibility.
• Medical, dental, and vision benefits.
• Paid time off, including summer and winter company shutdowns.
• Educational assistance, student loan repayment support, commuting subsidy, charitable donation matching, and 401(k).
• Continuous learning opportunities in AI, technology, automation, and industry trends.