Remote Pharmacovigilance Operations Manager

Parexel; Jackson (MS); Remote; USD 110,000 - 170,000; Full time

Benefits offered by this job

Health, Vision & Dental 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 seeking a Manager, Patient Safety Operations (Pharmacovigilance Operations Manager) to join our team in a remote capacity. You will guide staff, ensure compliance with regulations, and collaborate with clients on safety activities across projects.

The role emphasizes process improvement, budget oversight, and adoption of automation tools to enhance PV workflows. You will lead teams, provide coaching, and coordinate with cross-functional groups while maintaining up-to-date knowledge of

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 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 and continuous improvement initiatives
• Maintain current knowledge of relevant regulations and client 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 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 safety

Pharmacovigilance operations

Line management

Client interaction

Automation in PV

Team collaboration

Education

Pharmacy/Nursing/Life Science degree

Tools

PV systems

Job description

Parexel is seeking a Manager, Patient Safety Operations (Pharmacovigilance Operations Manager) to join our team in a remote capacity. You will guide staff, ensure compliance with regulations, and collaborate with clients on safety activities across projects.

The role emphasizes process improvement, budget oversight, and adoption of automation tools to enhance PV workflows. You will lead teams, provide coaching, and coordinate with cross-functional groups while maintaining up-to-date knowledge of