**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.
\#LI-LB1
\#LI-REMOTE
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.