Remote Pharmacovigilance Operations Manager

Parexel; Phoenix (AZ); A distancia; USD 120.000 - 160.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health, Vision & Dental Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending & Health Savings

Work/Life Balance

401(k) with Company match

Pet Insurance

Descripción de la vacante

Parexel is seeking a Manager, Patient Safety Operations to join our team in a remote capacity. You will supervise Pharmacovigilance staff, ensure timely safety processing, and maintain compliance with regulations and SOPs.

You will lead process improvements, coordinate budgets, advise clients, and collaborate across functions to deliver high-quality safety services for clinical research and patient protection.

Formación

• Degree in Pharmacy, Nursing, Life Science, or another health-related field, or equivalent qualification or relevant work experience
• People management experience
• Considerable experience working with clients
• Understanding of ICH, CIOMS, GVP, and basic pharmacovigilance requirements
• Effective communication and teamwork skills

Responsabilidades

• Manage and develop Patient Safety staff, delegate work according to allocated budgets and hours, and coordinate resource assignments and staffing needs with appropriate leaders
• Guide day-to-day team performance, create development plans, provide coaching and training, conduct appraisals, and address performance concerns
• Ensure assigned work meets Service Level Agreements and defined KPIs for quality, compliance, and training
• Provide functional expertise and oversight for Patient Safety processes, respond to team queries, and support urgent workload requirements when needed
• Execute Patient Safety activities aligned with team objectives, implement resource utilization plans, and contribute to process improvement
• Maintain knowledge of relevant regulations and Parexel SOPs, and support audits, inspections, quality investigations, risk mitigation, and response activities
• Manage project budgets and resource allocation, forecast resource needs, track performance metrics, manage client expectations, and identify scope changes for escalation
• Maintain professional client interactions, participate in client and team meetings, address feedback and concerns, and provide periodic project updates to Senior Management
• Coordinate team activities, review and validate timesheets, communicate key decisions and policies, support team cohesion, and collaborate with cross-functional teams
• Participate in implementation and optimization of pharmacovigilance automation tools and digital solutions, support adoption through training, and analyze performance
• Assess emerging technologies, recommend safety workflow improvements, and contribute to innovation roadmaps that enhance efficiency and compliance
• Provide technical input for business development activities and support preparation of materials and presentations

Conocimientos

Clinical knowledge

Regulatory knowledge

Safety services knowledge

Leadership

Client interaction

Educación

Health-related degree

Herramientas

Pharmacovigilance automation tools

Descripción del empleo

Parexel is seeking a Manager, Patient Safety Operations to join our team in a remote capacity. You will supervise Pharmacovigilance staff, ensure timely safety processing, and maintain compliance with regulations and SOPs.

You will lead process improvements, coordinate budgets, advise clients, and collaborate across functions to deliver high-quality safety services for clinical research and patient protection.