Remote Patient Safety Operations Manager

Parexel; United States; À distance; USD 120 000 - 170 000; Plein temps

Avantages offerts par ce poste

Health, Vision & Dental Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending & Health Savings

Work/Life Balance

401(k) with Company match

Pet Insurance

Résumé du poste

Parexel is seeking a Manager, Patient Safety Operations to lead pharmacovigilance teams remotely in the United States. You will guide day-to-day performance, ensure regulatory compliance, and provide process expertise across safety activities including ICSR processing, signal management, and medical writing.

You will partner with clients, drive continuous improvement, manage budgets and staffing, and support automation tools to enhance safety workflows and audit readiness.

Qualifications

• Extensive knowledge of pharmacovigilance operations and clinical research methodologies.
• Experience coaching and developing staff, and working with clients.
• Understanding of ICH, CIOMS, GVP, and PV regulatory requirements.
• Familiarity with automation and AI applications in pharmacovigilance.

Responsabilités

• Manage and supervise Patient Safety staff across projects, ensuring quality, timelines, and training.
• Provide process expertise in safety activities including ICSRs, signal management, and medical writing.
• Communicate with clients to address questions, feedback, and escalations.
• Oversee budgets, resource allocation, and forecasting; monitor KPIs and SLAs.
• Support audits, inspections, risk mitigation, and continuous improvement initiatives.

Connaissances

Pharmacovigilance operations

Client interaction

Line management

Automation in PV

Formation

Degree in Pharmacy, Nursing, Life Science, or health-related field

Description du poste

Parexel is seeking a Manager, Patient Safety Operations to lead pharmacovigilance teams remotely in the United States. You will guide day-to-day performance, ensure regulatory compliance, and provide process expertise across safety activities including ICSR processing, signal management, and medical writing.

You will partner with clients, drive continuous improvement, manage budgets and staffing, and support automation tools to enhance safety workflows and audit readiness.