Remote Patient Safety Operations Leader

Parexel; Trenton (NJ); Remote; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health insurance

401(k) match

Tuition reimbursement

Vacation time

Flexible Spending Account

Work/Life Balance

Job summary

Parexel is seeking a Manager, Patient Safety Operations (Pharmacovigilance Operations Manager) to lead safety staff remotely. You will oversee daily performance, quality, and timelines, providing process expertise in case processing, signal management, and safety writing, while ensuring regulatory compliance and client satisfaction.

You will guide teams, manage budgets, and collaborate with cross-functional groups to deliver high-quality safety services essential to clinical research and patient

Qualifications

• Excellent clinical, regulatory, and medical Safety Services knowledge.
• Working knowledge of pharmacovigilance operations and clinical research methodologies.
• Line management experience and ability to coach, develop, and communicate with staff.
• Experience interacting professionally with clients and collaborating across functions.
• Awareness of automation and AI applications in pharmacovigilance.
• Adaptive mindset with learning, continuous improvement, and teamwork.

Responsibilities

• Manage and develop Patient Safety staff, delegate work within budgets and hours, coordinate staffing with leaders.
• Guide day-to-day team performance, develop plans, provide coaching and training, conduct appraisals.
• Ensure work meets SLAs and KPIs for quality, compliance, and training.
• Provide functional expertise for Patient Safety processes and support urgent workload needs.
• Execute safety activities aligned with team objectives and drive process improvements.
• Maintain knowledge of regulations and SOPs; support audits and risk mitigation.
• Manage project budgets, forecast resources, and communicate with clients.
• Maintain client interactions and provide project updates to Senior Management.
• Coordinate team activities, review timesheets, and share policy decisions.
• Support pharmacovigilance automation tool implementations and training.
• Assess technologies and contribute to safety workflow improvements.
• Contribute to business development materials and presentations.

Skills

Pharmacovigilance operations

Client management

Staff coaching

Regulatory knowledge

Automation in pharmacovigilance

Team leadership

Budget management

Education

Health sciences degree

Tools

Pharmacovigilance automation tools

Job description

Parexel is seeking a Manager, Patient Safety Operations (Pharmacovigilance Operations Manager) to lead safety staff remotely. You will oversee daily performance, quality, and timelines, providing process expertise in case processing, signal management, and safety writing, while ensuring regulatory compliance and client satisfaction.

You will guide teams, manage budgets, and collaborate with cross-functional groups to deliver high-quality safety services essential to clinical research and patient