Remote Pharmacovigilance Operations Manager

Parexel; Madison (WI); Remote; USD 120,000 - 170,000; Full time

Benefits offered by this job

Health insurance

Tuition reimbursement

Vacation/holiday/sick time

Flexible Spending & Health Savings

Work/Life Balance

401(k) with Company match

Pet Insurance

Job summary

Parexel is hiring a Manager, Patient Safety Operations to oversee Pharmacovigilance operations, guide safety staff, ensure quality and timelines, and interact with clients. This remote-capable role emphasizes process excellence, regulatory compliance, and continuous improvement within a global clinical research environment.

You will lead team development, manage budgets, and coordinate with cross-functional groups while staying current with evolving safety regulations and Parexel SOPs.

Qualifications

• 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
• 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

Responsibilities

• 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 Key Performance Indicators 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 and continuous improvement initiatives
• Maintain current knowledge of relevant regulations and client and Parexel Standard Operating Procedures, 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 potential 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 the implementation and optimization of pharmacovigilance automation tools and digital solutions, support team adoption through training, and analyze automated process performance
• Assess emerging technologies, recommend improvements to safety workflows, and contribute to innovation roadmaps that enhance efficiency and compliance
• Provide technical input for business development activities and support the preparation of materials and presentations as requested

Skills

Clinical knowledge

Regulatory knowledge

Medical safety services

Line management

Client interaction

Automation awareness in pharmacovigil

Adaptability

Education

Degree in Pharmacy or life sciences

Job description

Parexel is hiring a Manager, Patient Safety Operations to oversee Pharmacovigilance operations, guide safety staff, ensure quality and timelines, and interact with clients. This remote-capable role emphasizes process excellence, regulatory compliance, and continuous improvement within a global clinical research environment.

You will lead team development, manage budgets, and coordinate with cross-functional groups while staying current with evolving safety regulations and Parexel SOPs.