Senior Patient Safety Project Lead

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

📋 Description

• Oversee comprehensive patient safety initiatives with full responsibility for delivery, quality, and financial outcomes.

• Provide leadership and guidance across project teams.

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

• Guarantee adherence to regulatory standards and operational excellence.

• Establish and nurture collaborative relationships with clients.

• Create proposals for patient safety services.

• Evaluate scope requirements and offer resource estimations.

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

• Serve as the sole contact for assigned partnerships.

• Develop and sustain project plans complete with milestones and timelines.

• Track task progress and execute corrective measures as needed.

• Manage budgets while comparing actual costs to planned expenditures.

• Oversee scope change management and revenue acknowledgment.

• Deliver regular status reports to clients and internal stakeholders.

• Collaborate with Project Analysts on financial issues.

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

• Cultivate relationships with external stakeholders and vendors.

• Provide guidance on ICH, FDA, EMA, and GCP compliance standards.

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

• Offer 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.

• Proven project management skills with a record of effective team leadership.

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

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

• Strong understanding of pharmacovigilance systems and regulatory requirements.

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

• Excellent written and verbal communication skills in English.

• Strong leadership and team-building capabilities.

• Advanced skills in prioritization and multitasking.

• Problem-solving skills to manage multiple complex projects effectively.

• Collaborative mindset suitable for matrix environments.

• Knowledge of clinical research and drug development processes.

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

🏝️ Benefits

• Opportunity to work with a dynamic and innovative team.

• Competitive salary and comprehensive benefits package.

• Professional development and growth opportunities.

• Flexible working arrangements.