Manager, Patient Safety

Parexel•Southport, NC

1d•Remote

About The Position

Parexel is seeking a Manager, Patient Safety Operations (also referred to as Pharmacovigilance Operations Manager or Drug Safety Operations Manager) to work remotely. The role manages and supervises Patient Safety staff supporting assigned projects, with responsibility for day-to-day performance, quality, timeline compliance, and training. It provides 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. The manager communicates directly with clients about questions, feedback, and escalations. The role supports team development, client partnership, cross-functional collaboration, continuous improvement, and technology-enabled ways of working to deliver high-quality safety services that support clinical research and patient protection. Parexel describes itself as a global clinical development partner with more than 22,000 employees worldwide, serving the life sciences industry.

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; coach and train staff; 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 and continuous improvement initiatives.
Maintain current knowledge of relevant regulations and client and Parexel Standard Operating Procedures; 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 implementing and optimizing 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 preparation of materials and presentations as requested.