Manager, Patient Safety

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

• 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.