Manager, Patient Safety

Parexel•United States-Massachusetts-Remote, MA

1d•Remote

About The Position

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.

Requirements

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

Nice To Haves

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

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.