Patient Safety ICSR Manager (Biotechnology)

Location: Boston, Massachusetts, United States. Remote-eligible with a choice of remote work five days per week and occasional office visits, hybrid work with up to two remote days per week, or on-site work five days per week.

Salary: $121,600–$182,400 per year, plus eligibility for an annual bonus and annual equity awards.

Company

Vertex is a global biotechnology company focused on scientific innovation.

What you will do

• Manage assigned Individual Case Safety Reports from receipt and book-in through closure, including triage, structured data entry, event coding, narrative writing, follow-up, and archiving.
• Review new and follow-up safety information and determine the appropriate data for entry into the Global Safety Database.
• Support timely ICSR reporting to health authorities and regulatory agencies, and distribute reports to vendors, business partners, and stakeholders.
• Perform database searches, case nullifications and deletions, business partner and vendor reconciliations, and Serious Adverse Event reconciliation.
• Interface with study sites, participate in cross-functional Study Execution Teams, and help develop safety reports and pharmacovigilance agreements.
• Improve ICSR processing efficiency, contribute to safety management system improvements, author procedures and working instructions, and mentor specialists and GPS staff.

Requirements

• Proficiency in Argus Safety and experience with individual case safety report processing.
• Bachelor’s degree or equivalent with 4–5 years of relevant experience, or PharmD, M.S.N., or equivalent degree with 3–5 years of relevant experience.
• Knowledge of international pharmacovigilance regulations and safety procedures.
• Effective written and oral communication skills, attention to detail, multitasking ability, and the ability to work autonomously in a matrix environment.
• Ability to understand established procedures and communicate them to others.

Nice to have

• Experience applying AI solutions to simplify processes and improve efficiency.
• Experience creating or authoring Standard Operating Procedures and Working Instructions.

Culture & Benefits

• Flexible work designation with remote, hybrid, or on-site options under the company’s Flex @ Vertex program.
• Medical, dental, and vision benefits.
• Generous paid time off, including week-long summer and winter company shutdowns.
• Educational assistance, including student loan repayment programs.
• Commuting subsidy, matching charitable donations, and 401(k).