Remote Pharmacovigilance Operations Manager

Parexel; Lower Paxton Township (PA); Remote; USD 120,000 - 180,000; 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 manage Patient Safety staff, guide day-to-day performance, and ensure timely, compliant safety activities across ICSR processing, signal and risk management, and safety medical writing.

You will collaborate with clients, oversee budgets and resources, and drive optimization through automation tools, contributing to high-quality safety services essential

Qualifications

• Degree in Pharmacy, Nursing, Life Science or related field.
• People management experience.
• Experience interacting with clients.
• Working knowledge of pharmacovigilance operations and clinical research methodologies.
• Excellent clinical, regulatory, and medical Safety Services knowledge.

Responsibilities

• Manage and develop Patient Safety staff and coordinate resource allocation.
• Guide day-to-day team performance and provide coaching and training.
• Ensure work meets SLAs and KPIs for quality and compliance.
• Provide functional oversight for Patient Safety processes and respond to queries.
• Execute safety activities aligned with team objectives and drive process improvements.
• Maintain knowledge of relevant regulations and support audits and inspections.
• Manage project budgets, forecast resources, and communicate with clients.
• Coordinate cross-functional teams and participate in client meetings.
• Support pharmacovigilance automation tools and analyze performance.
• Contribute to innovation roadmaps for safety workflows.

Skills

People management

Client engagement

Pharmacovigilance operations

Regulatory knowledge

Automation in PV

Education

Degree in Pharmacy, Nursing, Life Science

Tools

PV systems

Automation tools

Job description

Parexel is seeking a Manager, Patient Safety Operations (Pharmacovigilance Operations Manager) to join our team in a remote capacity. You will manage Patient Safety staff, guide day-to-day performance, and ensure timely, compliant safety activities across ICSR processing, signal and risk management, and safety medical writing.

You will collaborate with clients, oversee budgets and resources, and drive optimization through automation tools, contributing to high-quality safety services essential