Patient Safety PVSci Manager

Vertex Inc.•Boston, MA

23h•$120,800 - $181,200•Remote

About The Position

The Global Patient Safety (GPS) Pharmacovigilance Science (PVSci) Manager leads assigned activities related to cross-functional safety data monitoring, assessment, and aggregate reporting to regulatory agencies, and support signal and risk management activities. At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.

Requirements

Communicates clearly and proactively with cross-functional teams and stakeholders
Demonstrates independence in managing assigned safety deliverables and timelines
Applies strong organizational and project management skills to coordinate multiple priorities and multi-task effectively
Analyzes, interprets, and summarizes data with guidance
Demonstrates firm comprehension of established procedures and may identify opportunities for improvement
Applies understanding of industry practices for drug development and pharmacovigilance
Fluent in use of electronic systems and rapidly adopts new technology to support documentation and reporting
Demonstrates a commitment to ongoing learning and professional development
Seeks feedback and incorporates it to enhance deliverables and processes
Minimum of 2 years pharmacovigilance or relevant experience, with data analysis and medical/scientific writing; preference for aggregate/periodic safety report preparation

Nice To Haves

Advanced healthcare degree (preferred) or equivalent professional experience

Responsibilities

Leads PVSci activities for assigned Vertex product, including coordinating review of emerging safety data and ensuring timely identification and communication of any potential safety issues
Prepares aggregate safety report content, including risk management plans and responses to regulatory authority requests
Conducts signal detection/tracking and other assessments/risk management activities
Provides project management support for PVSci deliverables by establishing and managing timelines, content planning and tracking, and coordinating activities across multiple GPS functions (e.g., safety database report requests)
Develops meeting materials to enable safety discussions within GPS forums (Aggregate Clinical Safety Team, Signal Management Team, and Disease Area Safety Team) and other cross-functional forums (e.g., data monitoring committee meetings, key results memos)
Supports development of safety content according to program strategy and timelines (e.g., clinical study reports, drug authorization applications)
Supports GPS Epidemiology-led study documentation
Liaises with Regulatory Affairs and other functions to coordinate submission of aggregate safety reports