Patient Safety PVSci Manager

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

• 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