When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient.
We take our work personally, we do it with empathy and we're committed to making a difference. 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-functi