Senior Patient Safety Project Lead
Parexel · Ireland
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Senior Patient Safety Project Lead
We're seeking a Senior Patient Safety Project Lead to manage comprehensive patient safety projects with full accountability for delivery, quality, and financial performance. You'll provide leadership and oversight across project teams, serve as the primary liaison between internal departments and clients, and ensure regulatory compliance and operational excellence.
This role is remote based in Ireland so you must be living there.
Key Responsibilities
Client Management
- 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
Project Management
- Develop and maintain comprehensive project plans with clear milestones and timelines
- Monitor task progression and implement corrective actions
- Manage budgets, comparing actual versus planned costs
- Oversee scope change management and revenue recognition
- Provide regular status updates to clients and internal stakeholders
- Coordinate with Project Analysts on financial matters
Cross-Functional Leadership
- Coordinate with internal teams (Business Operations, Clinical Operations, Data Management)
- Manage relationships with external stakeholders and vendors
- Provide guidance on regulatory compliance (ICH, FDA, EMA, GCP)
- Partner with Subject Matter Experts to improve processes and methodologies
- Provide functional oversight and may supervise direct reports
Quality & Compliance
- Ensure deliverables meet client expectations and regulatory standards
- Maintain current knowledge of industry regulations and patient safety trends
- Apply expertise in pharmacovigilance systems and safety database management
- Support Clinical Adjudication Committees (CACs) and Data Monitoring Committees (DMCs)
Required Experience
- 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
Required Skills
- 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
Education
- Degree in Pharmacy, Nursing, Life Science, or related health field (or equivalent pharmacovigilance experience)
- Project management certification is advantageous