Senior Patient Safety Project Lead

This is a fully remote position, open to applicants in Ireland.

📋 Description

• Oversee extensive patient safety initiatives while ensuring accountability for delivery, quality, and financial results.

• Provide strategic leadership and guidance across various project teams.

• Act as the main point of contact between internal departments and clients.

• Ensure adherence to regulatory standards and operational excellence.

• Foster and sustain collaborative relationships with clients.

• Create proposals for patient safety services.

• Evaluate scope requirements and deliver resource estimations.

• Represent Parexel in client meetings, bid defenses, and governance discussions.

• Serve as the sole point of contact for designated partnerships.

• Develop and maintain project plans outlining milestones and timelines.

• Monitor task progress and implement necessary corrective measures.

• Manage budgets and analyze actual costs against planned expenditures.

• Supervise scope change management and oversee revenue recognition.

• Provide regular status updates to clients and internal stakeholders.

• Collaborate with Project Analysts on financial issues.

• Coordinate with Business Operations, Clinical Operations, and Data Management teams.

• Manage relationships with external stakeholders and vendors.

• Offer guidance on ICH, FDA, EMA, and GCP regulatory compliance.

• Collaborate with Subject Matter Experts to enhance processes and methodologies.

• Provide functional oversight and may supervise direct reports.

• Ensure that deliverables align with client expectations and regulatory standards.

• Stay informed about industry regulations and trends in patient safety.

• Utilize expertise in pharmacovigilance systems and safety database management.

• Support Clinical Adjudication Committees and Data Monitoring Committees.

⛳️ Requirements

• Extensive experience in drug development, healthcare, or pharmacovigilance.

• Demonstrated project management experience with proven team leadership capabilities.

• Specialized knowledge in clinical adjudication and data monitoring committee workflows.

• Proficient in IDRA workflows, committee governance, and adjudication technology platforms.

• Strong understanding of pharmacovigilance systems and relevant regulatory requirements.

• Expertise in contract management, budget planning, and revenue recognition.

• Excellent written and verbal communication skills in English.

• Strong leadership and team-building skills.

• Proficient in budget planning and financial management.

• Advanced skills in prioritization and multitasking.

• Strong problem-solving abilities with a capacity to manage multiple complex projects.

• Collaborative approach in matrix environments.

• Knowledge of clinical research and drug development processes.

• Strong written and verbal communication abilities.

• Degree in Pharmacy, Nursing, Life Science, or a related health field (or equivalent experience in pharmacovigilance).

🏝️ Benefits

• Opportunity for remote work based in Ireland.