Senior Patient Safety Project Lead

Parexel; Dublin; Remote; EUR 120,000 - 160,000; Full time

Job summary

Parexel is seeking a Senior Patient Safety Project Lead to manage comprehensive patient safety projects with full accountability for delivery, quality, and financial performance. You will provide leadership across project teams and serve as the primary liaison between internal departments and clients.

This remote role based in Ireland requires strong expertise in pharmacovigilance, regulatory standards (ICH, FDA, EMA, GCP), and experience with clinical adjudication and data monitoring

Qualifications

• Extensive experience in drug development, healthcare, or pharmacovigilance.
• Proven PM experience with team leadership.
• Experience in clinical adjudication and DMC processes.
• Knowledge of pharmacovigilance systems and regulatory requirements.
• Fluent written and verbal English.

Responsibilities

• Build and sustain collaborative client relationships.
• Develop proposals for patient safety services.
• Manage project plans, milestones and budgets.
• Provide status updates to clients and stakeholders.
• Ensure regulatory compliance (ICH, FDA, EMA, GCP).

Skills

Leadership

Budgeting

Prioritization

Multitasking

Problem-solving

Matrix environment

Clinical research

Communication

Education

Degree in Pharmacy, Nursing, Life Science, or related health field

Project management certification

Tools

IDRA workflows

Adjudication platforms

Job description

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

• 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