Senior Patient Safety Project Lead

Parexel; EUA; Teletrabalho; USD 135 000 - 180 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Resumo da oferta

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’ll provide leadership across project teams, and ensure regulatory compliance while coordinating with clients and internal stakeholders.

This remote-based role is in Ireland and requires living there. You will oversee budgets, governance, and cross-functional collaboration to optimize safety outcomes across trials.

Qualificações

• Extensive drug development, healthcare or pharmacovigilance experience.
• Proven project management experience with team leadership.
• Specialized experience in pharmacovigilance adjudication and DMC processes.
• Knowledge of IDRA workflows, governance and adjudication platforms.
• Strong knowledge of regulatory requirements in pharmacovigilance.

Responsabilidades

• Lead client relationships and proposals for patient safety services.
• Develop and manage project plans with milestones and budgets.
• Represent Parexel at client meetings and governance forums.
• Oversee scope changes and revenue recognition for projects.
• Provide regular status updates to clients and internal stakeholders.
• Coordinate with Project Analysts on financial matters.

Conhecimentos

Leadership

Budget planning

Prioritization

Problem-solving

Matrix collaboration

Clinical research knowledge

Communication

English fluency

Formação académica

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

Project management certification

Descrição da oferta de emprego

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