Patient Safety Project Lead
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.
Shape the Future of Patient Safety at Parexel
Are you a strategic thinker with a passion for patient safety and project leadership? Parexel is seeking a dynamic Patient Safety Project Lead (PSPL) to spearhead high-impact safety initiatives across full-service, functional, and standalone projects. This pivotal role blends strategic oversight with hands-on leadership, driving client satisfaction, optimizing resources, and ensuring top-tier quality and compliance in every facet of patient safety.
As a PSPL, you’ll be the connective force between cross-functional teams, sponsor stakeholders, and medical experts—serving as the primary liaison on full-service projects and collaborating closely with the Global Lead Physician. Whether guiding Clinical Adjudication Committees (CAC), supporting Data Monitoring Committees (DMC), or leading specialized safety scopes, you’ll be at the forefront of regulatory excellence and operational innovation.
Client Liaison & Service Excellence
Supports establishment of collaborative client relationships that foster trust, efficiency, and professional engagement
Implement data-driven performance metrics and key performance indicators to quantitatively measure success and drive continuous improvement for assigned projects
Proactively address client concerns, providing timely solutions and feedback to safety services management
Contribute knowledge to proposal development for standalone through end-to-end safety services
Assess service scope requirements, providing detailed task descriptions and resource estimations
Represent Parexel patient safety services at business development meetings, bid defenses, and client governance forums as needed
Project Management Mastery
Develop and maintain comprehensive project plans with clear milestones, deliverables, and timelines
Monitor task progression and overall program performance, implementing corrective actions as needed
Facilitate transparent communication regarding project status to clients and internal stakeholders
Conduct regular financial oversight, comparing actual versus planned budgets and optimizing resource utilization
Provide forecasting to patient safety services management, proposing innovative solutions for timeline shifts and staffing requirements
Ensure proper scope change management to maintain project profitability
Oversee revenue recognition, forecasting activities, and contractual invoicing for small standalone projects, or supports these activities proactively for full-service projects
Serve as primary point of contact for financial matters, coordinating with Project Analysts, related to patient safety services
Represent patient safety services during external audits, addressing findings and implementing improvements
Cross-Functional Collaboration
Coordinate seamlessly with internal teams (e.g., Business Operations, Clinical Operations, Data Management, Safety technology)
Manage relationships with external patient safety stakeholders (clients, vendors, health authorities)
Provide expert guidance on process-related issues in accordance with ICH, FDA, EMA, and other applicable guidelines
Partner with Subject Matter Experts to enhance quality, efficiency, and project management methodologies
Quality & Compliance Leadership
Ensure consistent delivery of high-quality deliverables that meet or exceed client expectations
Stay current with industry advances, regulatory updates, and emerging trends in patient safety
Apply in-depth knowledge of pharmacovigilance systems and regulatory requirements
Maintain compliance with ICH, GCP, and relevant geographic regulations
General
Foster a positive, results-oriented work environment that emphasizes partnership and teamwork
Communicate openly, transparently, and objectively with team members
Provide leadership and coverage during management absences
May supervise direct reports and provide functional oversight across the SBU when required
Skills:
Leadership abilities with demonstrated success in building effective project teams
Strong motivational skills with proven ability to delegate effectively and make quality decisions
Proficient knowledge of pharmacovigilance technology and systems and safety database management
Familiarity with business operating procedures including contract management, revenue recognition, and project lifecycle management
Effective budget planning and financial management experience
Ability to prioritize effectively and manage multiple projects simultaneously
Collaborative mindset with demonstrated success in matrix environments
Proactive problem-solving approach with ability to create appropriate sense of urgency
Strong understanding of clinical research processes and drug development lifecycle
Robust written and verbal communication skills
Knowledge and Experience:
Extensive drug safety knowledge with substantial experience in pharmacovigilance
Minimum 5+ years working in drug development and/or healthcare environments
Proven project management experience with demonstrated team leadership capabilities
Strong command of written and spoken English; additional language proficiency as required
Established track record of developing and maintaining client relationships
Specialized experience in clinical adjudication and data monitoring committee processes, specifically for CAC and DMC projects management
Proficiency with IDRA workflows, committee governance, and adjudication technology platforms, specifically for CAC and DMC projects management
Comprehensive understanding of pharmacovigilance systems and regulatory requirements
Education:
Degree in Pharmacy, Nursing, Life Science, or other health-related field, or relevant work experience in Pharmacovigilance.
A certification in project management is an advantage.
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EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.