Remote Pharmacovigilance Operations Manager

Parexel; Columbus (OH); Remote; USD 110,000 - 140,000; 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 to lead Pharmacovigilance activities for multiple projects in a remote capacity. You will supervise Patient Safety staff, ensure compliance with regulatory standards, and manage client communications, timelines, and budgets.

You will drive process improvements, leverage automation tools, and align safety activities with project objectives while maintaining high quality and patient safety standards across programs.

Qualifications

• Degree in Pharmacy, Nursing, Life Science, or related health field.
• Proven people management experience.
• Experience working with clients in a pharmacovigilance context.
• Strong knowledge of ICH, CIOMS, GVP requirements.
• Excellent clinical, regulatory, and medical Safety Services knowledge.
• Effective communication and teamwork skills.

Responsibilities

• Lead and develop Patient Safety staff, manage budgets and staffing.
• Provide coaching, training, and performance feedback.
• Ensure SLAs and KPIs for quality and training.
• Oversee safety processes, respond to queries, support urgent workloads.
• Support pharmacovigilance automation tools and digital solutions.
• Maintain knowledge of regulations and support audits/inspections.
• Forecast resource needs and manage client expectations.
• Coordinate cross-functional teams and client meetings.
• Contribute to process improvements and project updates.

Skills

Pharmacovigilance operations

Clinical safety knowledge

Regulatory knowledge

People management

Client communication

Automation awareness

Team coaching

Budget/Resource planning

Education

Health-related degree (Pharmacy/Nursing/Life Science)

Tools

Pharmacovigilance automation tools

Job description

Parexel is seeking a Manager, Patient Safety Operations to lead Pharmacovigilance activities for multiple projects in a remote capacity. You will supervise Patient Safety staff, ensure compliance with regulatory standards, and manage client communications, timelines, and budgets.

You will drive process improvements, leverage automation tools, and align safety activities with project objectives while maintaining high quality and patient safety standards across programs.