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 EXPERIENCE

• Advanced 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:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. 

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Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com