Manager, Patient Safety

Parexel; United States; Remote; USD 120,000 - 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 to lead pharmacovigilance teams remotely in the United States. You will guide day-to-day performance, ensure regulatory compliance, and provide process expertise across safety activities including ICSR processing, signal management, and medical writing.

You will partner with clients, drive continuous improvement, manage budgets and staffing, and support automation tools to enhance safety workflows and audit readiness.

Qualifications

• Extensive knowledge of pharmacovigilance operations and clinical research methodologies.
• Experience coaching and developing staff, and working with clients.
• Understanding of ICH, CIOMS, GVP, and PV regulatory requirements.
• Familiarity with automation and AI applications in pharmacovigilance.

Responsibilities

• Manage and supervise Patient Safety staff across projects, ensuring quality, timelines, and training.
• Provide process expertise in safety activities including ICSRs, signal management, and medical writing.
• Communicate with clients to address questions, feedback, and escalations.
• Oversee budgets, resource allocation, and forecasting; monitor KPIs and SLAs.
• Support audits, inspections, risk mitigation, and continuous improvement initiatives.

Skills

Pharmacovigilance operations

Client interaction

Line management

Automation in PV

Education

Degree in Pharmacy, Nursing, Life Science, or health-related field

Job description

About Parexel

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.

We work with focus, agility, and shared purpose, moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry-leading innovation, With Heart.

About the Role

We are seeking a Manager, Patient Safety Operations (Pharmacovigilance Operations Manager, Drug Safety Operations Manager) to join our team in a remote capacity.

As a Manager, Patient Safety Operations, you will manage and supervise Patient Safety staff supporting assigned projects, guiding day-to-day performance, quality, timeline compliance, and training. You will provide process expertise across project-specific safety activities, including Individual Case Safety Report processing, signal and risk management, and safety medical writing, while maintaining compliance with applicable regulations and Standard Operating Procedures. You will also communicate directly with clients to address questions, feedback, and escalations.

You will join a collaborative environment where you can strengthen team capabilities, improve pharmacovigilance operations, and support technology-enabled ways of working. Through team development, client partnership, cross-functional collaboration, and continuous improvement, you will help deliver high-quality safety services that are essential to clinical research and patient protection.

Key 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.

Candidate Profile

You'll thrive in this role if you bring:

• Excellent clinical, regulatory, and medical Safety Services knowledge
• Working knowledge of pharmacovigilance operations and clinical research methodologies
• Line Management experience and the ability to coach, develop, and communicate effectively with staff
• Experience interacting professionally with clients and working collaboratively across functions
• Awareness of automation and artificial intelligence applications in pharmacovigilance
• An adaptable mindset with enthusiasm for learning, continuous improvement, and teamwork

Required 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

Preferred Qualifications

• Familiarity with pharmacovigilance process improvements, automation tools, and digital solutions
• Knowledge of pharmacovigilance audit and inspection requirements
• Understanding of project budget management, resource allocation, and resource forecasting principles
• Awareness of automation and artificial intelligence applications in pharmacovigilance

Benefits and Compensation

• Health, Vision & Dental Insurance
• Tuition Reimbursement
• Vacation/Holiday/Sick Time
• Flexible Spending & Health Savings Accounts
• Work/Life Balance
• 401(k) with Company match
• Pet Insurance

For a complete list of benefits, please visit www.parexel.com/us-benefits.

We offer a comprehensive benefits package to eligible employees, which includes paid time off, a 401(k) match, life insurance, health insurance, and additional benefit offerings in accordance with the terms of our applicable plans.

We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.

#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.