Senior Patient Safety Project Lead

🕒 September 1

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 12%

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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

• Establish and maintain collaborative client relationships • Lead patient safety programs and partnerships by developing project plans, managing milestones, monitoring performance, and ensuring timely delivery • Oversee budgeting, forecasting, resource planning, revenue recognition, invoicing, and scope change management • Serve as a key client contact, address challenges, communicate project status, and coordinate solutions • Contribute subject matter expertise to proposals, business development activities, bid defenses, and governance meetings • Collaborate with Business Operations, Clinical Operations, Data Management, and other cross-functional teams • Partner with clients, vendors, health authorities, and internal subject matter experts • Ensure deliverables meet quality standards and comply with ICH, GCP, FDA, EMA, and other regulatory requirements • Apply advanced knowledge of pharmacovigilance systems, safety processes, and regulatory expectations • Stay current with industry trends, emerging regulations, and best practices • Represent Patient Safety during audits and support corrective and preventive actions • Provide leadership, mentorship, and functional oversight across teams

🎯 Requirements

• Degree in Pharmacy, Nursing, Life Science, or other health related field, or relevant work experience in Pharmacovigilance • Minimum 7+ years of experience in drug development and/or healthcare environments • Experience with managing safety stand-alone projects • Extensive drug safety and pharmacovigilance experience with demonstrated project management and team leadership capabilities • Strong knowledge of ICH, GCP, regulatory requirements, and pharmacovigilance processes • Experience working with pharmacovigilance systems, safety databases, and project lifecycle management processes • Strong communication, organization, financial management, and decision making skills • Strong command of written and spoken English

🏖️ Benefits

• Health, Vision & Dental Insurance • Tuition Reimbursement • Vacation/Holiday/Sick Time • Flexible Spending & Health Savings Accounts • Work/Life Balance • 401(k) with Company match • Pet Insurance • Paid time off • Life insurance • Additional benefit offerings in accordance with applicable plans