Global PVSci Manager — Patient Safety & Signals

Vertex Inc.; United States; Remote; USD 121,000 - 181,000; Full time

Benefits offered by this job

Remote-Eligible

Annual bonus

Equity awards

Total Rewards

Job summary

Vertex Inc. is seeking a Global Patient Safety Pharmacovigilance Science Manager to lead cross-functional safety data monitoring and aggregate reporting, including risk management activities.

You will coordinate reviews of emerging safety data and support regulatory submissions while guiding safety discussions across GPS forums. The role emphasizes program strategy, timelines, and collaboration with Regulatory Affairs and other functions to ensure compliant safety deliverables.

Qualifications

• Minimum 2 years pharmacovigilance or relevant experience, with data analysis and medical writing.
• Preference for aggregate/periodic safety report preparation.

Responsibilities

• Leads PVSci activities for Vertex product, coordinating review of safety data and communication of potential safety issues.
• Prepares aggregate safety report content, including risk management plans and responses to regulatory requests.
• Conducts signal detection and risk management activities.
• Provides project management support for PVSci deliverables across GPS functions.
• Develops meeting materials to enable safety discussions in GPS forums and cross-functional meetings.
• Supports development of safety content according to program strategy and timelines.
• Liaises with Regulatory Affairs to coordinate submission of aggregate safety reports.

Skills

Pharmacovigilance

Project management

Data analysis

Medical writing

Regulatory knowledge

Cross-functional teams

Education

Advanced healthcare degree (preferred)

Tools

Safety databases

Job description

Vertex Inc. is seeking a Global Patient Safety Pharmacovigilance Science Manager to lead cross-functional safety data monitoring and aggregate reporting, including risk management activities.

You will coordinate reviews of emerging safety data and support regulatory submissions while guiding safety discussions across GPS forums. The role emphasizes program strategy, timelines, and collaboration with Regulatory Affairs and other functions to ensure compliant safety deliverables.