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 ParexelAre 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 ExcellenceSupports establishment of collaborative client relationships that foster trust, efficiency, and professional engagementImplement data-driven performance metrics and key performance indicators to quantitatively measure success and drive continuous improvement for assigned projectsProactively address client concerns, providing timely solutions and feedback to safety services managementContribute knowledge to proposal development for standalone through end-to-end safety servicesAssess service scope requirements, providing detailed task descriptions and resource estimationsRepresent Parexel patient safety services at business development meetings, bid defenses, and client governance forums as neededProject Management MasteryDevelop and maintain comprehensive project plans with clear milestones, deliverables, and timelinesMonitor task progression and overall program performance, implementing corrective actions as neededFacilitate transparent communication regarding project status to clients and internal stakeholdersConduct regular financial oversight, comparing actual versus planned budgets and optimizing resource utilizationProvide forecasting to patient safety services management, proposing innovative solutions for timeline shifts and staffing requirementsEnsure proper scope change management to maintain project profitabilityOversee revenue recognition, forecasting activities, and contractual invoicing for small standalone projects, or supports these activities proactively for full-service projectsServe as primary point of contact for financial matters, coordinating with Project Analysts, related to patient safety servicesRepresent patient safety services during external audits, addressing findings and implementing improvementsCross-Functional CollaborationCoordinate 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 guidelinesPartner with Subject Matter Experts to enhance quality, efficiency, and project management methodologiesQuality & Compliance LeadershipEnsure consistent delivery of high-quality deliverables that meet or exceed client expectationsStay current with industry advances, regulatory updates, and emerging trends in patient safetyApply in-depth knowledge of pharmacovigilance systems and regulatory requirementsMaintain compliance with ICH, GCP, and relevant geographic regulationsGeneralFoster a positive, results-oriented work environment that emphasizes partnership and teamworkCommunicate openly, transparently, and objectively with team membersProvide leadership and coverage during management absencesMay supervise direct reports and provide functional oversight across the SBU when requiredSkills:Leadership abilities with demonstrated success in building effective project teamsStrong motivational skills with proven ability to delegate effectively and make quality decisionsProficient knowledge of pharmacovigilance technology and systems and safety database managementFamiliarity with business operating procedures including contract management, revenue recognition, and project lifecycle managementEffective budget planning and financial management experienceAbility to prioritize effectively and manage multiple projects simultaneouslyCollaborative mindset with demonstrated success in matrix environmentsProactive problem-solving approach with ability to create appropriate sense of urgencyStrong understanding of clinical research processes and drug development lifecycleRobust written and verbal communication skillsKnowledge and Experience:Extensive drug safety knowledge with substantial experience in pharmacovigilanceMinimum 5+ years working in drug development and/or healthcare environmentsProven project management experience with demonstrated team leadership capabilitiesStrong command of written and spoken English; additional language proficiency as requiredEstablished track record of developing and maintaining client relationshipsSpecialized experience in clinical adjudication and data monitoring committee processes, specifically for CAC and DMC projects managementProficiency with IDRA workflows, committee governance, and adjudication technology platforms, specifically for CAC and DMC projects managementComprehensive understanding of pharmacovigilance systems and regulatory requirementsEducation: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-LB1EEO DisclaimerParexel 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.