Global ICSR & Patient Safety Manager — Remote

Vertex Pharmaceuticals; Boston (MA); On-site; USD 122,000 - 182,000; Full time

Job summary

Vertex Pharmaceuticals is seeking a Global Patient Safety ICSR Manager to lead end-to-end ICSR processing, including book-in, entry, coding, narrative writing, and follow-up. This role requires working independently, troubleshooting, and ensuring compliance with regulatory guidelines.

You will mentor GPS staff, support reporting to health authorities, and collaborate with cross-functional teams to improve safety processes.

Qualifications

• B.S. (or equivalent) with 4–5 years in PV or PharmD/MSN with 3–5 years of relevant work experience.
• Strong knowledge of ICSR processing and regulatory requirements.
• Proficiency with Argus Safety or similar safety databases.

Responsibilities

• Performs workflow management activities, in addition to contributing in individual workflows
• Monitors GPS Inbox for receipt of safety information
• Performs initial ICSR book-in activities, including determination of a valid case and follow-up information
• Archives ICSR documentation per procedures
• Reviews and interprets new safety information for database entry
• Manages all assigned IC-SRs from receipt to ICSR closure
• Supports timely reporting of IC-SRs to Health Authorities and distribution to vendors
• Performs periodic Global Safety Database searches
• Provides feedback on quality and periodic reviews
• Mentors other Specialists and GPS staff

Skills

Effective communication

Multi-tasking

Independent worker

Team player

Attention to detail

Procedures understanding

Education

B.S. or equivalent degree +4-5 years

PharmD, MSN or equivalent +3-5 years

Tools

Argus Safety

AI solutions adoption

Job description

Vertex Pharmaceuticals is seeking a Global Patient Safety ICSR Manager to lead end-to-end ICSR processing, including book-in, entry, coding, narrative writing, and follow-up. This role requires working independently, troubleshooting, and ensuring compliance with regulatory guidelines.

You will mentor GPS staff, support reporting to health authorities, and collaborate with cross-functional teams to improve safety processes.