Patient Safety PVSci Manager

Job Description GENERAL POSITION SUMMARY 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.

KEY 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 Data Review, 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 GENERAL RESPONSIBILITIES AND REQUIRED SKILLS 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 EDUCATION AND EXPERIENCEAdvanced healthcare degree (preferred) or equivalent professional experience

Minimum of 2 years pharmacovigilance or relevant experience, with data analysis and medical/scientific writing; preference for aggregate/periodic safety report preparation

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.

Pay Range:$120,800 - $181,200

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their…