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

Senior Patient Safety Project Lead

Job Description