Senior Patient Safety Project Lead

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

#LI-REMOTE