Manager, Patient Safety

🕒 September 9

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 10%

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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 and supervise Patient Safety staff supporting assigned projects • Guide day-to-day performance, quality, timeline compliance, and training • Delegate work according to allocated budgets and hours and coordinate resource assignments • Create development plans, provide coaching and training, conduct appraisals, and address performance concerns • Ensure work meets Service Level Agreements and Key Performance Indicators • Provide functional expertise and oversight for Patient Safety processes • Execute Patient Safety activities and contribute to process improvement initiatives • Maintain knowledge of regulations and Standard Operating Procedures • Support audits, inspections, quality investigations, risk mitigation, and response activities • Manage project budgets and resource allocation, forecast resource needs, and track performance metrics • Manage client expectations, address feedback and concerns, and provide project updates to Senior Management • Coordinate team activities, review and validate timesheets, and collaborate with cross-functional teams • Participate in implementing and optimizing pharmacovigilance automation tools and digital solutions • Assess emerging technologies and recommend improvements to safety workflows • Provide technical input for business development activities and support preparation of materials and presentations

🎯 Requirements

• Degree in Pharmacy, Nursing, Life Science, another health-related field, or equivalent qualification or relevant work experience • People management experience • Considerable experience working with clients • Working knowledge of pharmacovigilance operations and clinical research methodologies • Excellent clinical, regulatory, and medical Safety Services knowledge • Understanding of ICH, CIOMS, GVP, and basic pharmacovigilance requirements • Effective communication and teamwork skills • Familiarity with pharmacovigilance process improvements, automation tools, and digital solutions preferred • Knowledge of pharmacovigilance audit and inspection requirements preferred • Understanding of project budget management, resource allocation, and resource forecasting principles preferred • Awareness of automation and artificial intelligence applications in pharmacovigilance • Candidates in other U.S. time zones must have flexibility to provide coverage during EST hours

🏖️ 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