Senior Patient Safety Project Lead

🔥 0 minutes ago

🇮🇪 Ireland – Remote

⏰ Full Time

🟠 Senior

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Manage comprehensive patient safety projects with accountability for delivery, quality, and financial performance • Provide leadership and oversight across project teams • Serve as primary liaison between internal departments and clients • Ensure regulatory compliance and operational excellence • Build and maintain collaborative client relationships • Develop proposals for patient safety services • Assess scope requirements and provide resource estimations • Represent Parexel at client meetings, bid defenses, and governance forums • Act as single point of contact for assigned partnerships • Develop and maintain project plans with milestones and timelines • Monitor task progression and implement corrective actions • Manage budgets and compare actual versus planned costs • Oversee scope change management and revenue recognition • Provide status updates to clients and internal stakeholders • Coordinate with Project Analysts on financial matters • Coordinate with Business Operations, Clinical Operations, and Data Management teams • Manage relationships with external stakeholders and vendors • Provide guidance on ICH, FDA, EMA, and GCP regulatory compliance • Partner with Subject Matter Experts to improve processes and methodologies • Provide functional oversight and potentially supervise direct reports • Ensure deliverables meet client expectations and regulatory standards • Maintain knowledge of industry regulations and patient safety trends • Apply expertise in pharmacovigilance systems and safety database management • Support Clinical Adjudication Committees and Data Monitoring Committees

🎯 Requirements

• Very strong experience in drug development, healthcare, or pharmacovigilance • Proven project management experience with demonstrated team leadership • Specialized experience in clinical adjudication and data monitoring committee processes • Proficiency with IDRA workflows, committee governance, and adjudication technology platforms • Strong knowledge of pharmacovigilance systems and regulatory requirements • Expertise in contract management, budget planning, and revenue recognition • Fluent written and verbal English communication • Leadership and team-building abilities • Budget planning and financial management • Advanced prioritization and multitasking • Problem-solving with ability to manage multiple complex projects • Collaborative approach to matrix environments • Understanding of clinical research and drug development processes • Strong written and verbal communication • Degree in Pharmacy, Nursing, Life Science, or related health field (or equivalent pharmacovigilance experience)

🏖️ Benefits

• Remote work based in Ireland