Senior Patient Safety Project Lead

• Manage comprehensive patient safety projects with accountability for delivery, quality, and financial performance
• Provide leadership and oversight across project teams
• Serve as primary liaison between internal departments and clients
• Ensure regulatory compliance and operational excellence
• Build and maintain collaborative client relationships
• Develop proposals for patient safety services
• Assess scope requirements and provide resource estimations
• Represent Parexel at client meetings, bid defenses, and governance forums
• Act as single point of contact for assigned partnerships
• Develop and maintain project plans with milestones and timelines
• Monitor task progression and implement corrective actions
• Manage budgets and compare actual versus planned costs
• Oversee scope change management and revenue recognition
• Provide status updates to clients and internal stakeholders
• Coordinate with Project Analysts on financial matters
• Coordinate with Business Operations, Clinical Operations, and Data Management teams
• Manage relationships with external stakeholders and vendors
• Provide guidance on ICH, FDA, EMA, and GCP regulatory compliance
• Partner with Subject Matter Experts to improve processes and methodologies
• Provide functional oversight and potentially supervise direct reports
• Ensure deliverables meet client expectations and regulatory standards
• Maintain knowledge of industry regulations and patient safety trends
• Apply expertise in pharmacovigilance systems and safety database management
• Support Clinical Adjudication Committees and Data Monitoring Committees

• Very strong experience in drug development, healthcare, or pharmacovigilance
• Proven project management experience with demonstrated team leadership
• Specialized experience in clinical adjudication and data monitoring committee processes
• Proficiency with IDRA workflows, committee governance, and adjudication technology platforms
• Strong knowledge of pharmacovigilance systems and regulatory requirements
• Expertise in contract management, budget planning, and revenue recognition
• Fluent written and verbal English communication
• Leadership and team-building abilities
• Budget planning and financial management
• Advanced prioritization and multitasking
• Problem-solving with ability to manage multiple complex projects
• Collaborative approach to matrix environments
• Understanding of clinical research and drug development processes
• Strong written and verbal communication
• Degree in Pharmacy, Nursing, Life Science, or related health field (or equivalent pharmacovigilance experience)

• Remote work based in Ireland