Head of Pharmacovigilance Operations

Role Overview

• Oversee end-to-end case processing operations, ensuring high-quality, scientifically accurate, timely, and compliant case management across global PV activities.
• Monitor regulatory compliance within case processing workflows, ensuring alignment with local and international requirements, including data privacy and governance standards.
• Drive continuous improvements in case quality and efficiency through operational benchmarking and implementation of best practices.
• Lead case processing transformation efforts through strategic outsourcing, automation, and workforce optimization to achieve operational excellence.
• Partner with HR to implement workforce change initiatives, including role repurposing, employee retraining, and organizational redesign.
• Develop and execute cost-saving strategies, transitioning PV operations from human-led to technology-driven processes.
• Foster a culture of innovation and continuous improvement to drive long-term organizational agility and adaptability.
• Oversee intake and triage processes, including the adoption of automation solutions for initial case processing stages.
• Ensure seamless integration of new intake and triage technologies into existing workflows, improving data capture and efficiency.
• Establish performance metrics and monitoring systems to evaluate the effectiveness of intake and triage operations.
• Build and maintain strong vendor relationships to ensure high performance, quality, and compliance in outsourced PV operations.
• Develop and establish an innovative vendor oversight and management model to drive ICSR excellence.
• Define and monitor key performance indicators (KPIs) and service-level agreements (SLAs) for vendor performance.
• Collaborate with vendors to implement quality improvement initiatives and address compliance challenges.
• Oversee vendor audits and risk assessments to ensure alignment with organizational and regulatory standards.
• Collaborate with internal stakeholders, including quality, and clinical teams, to align the case management function with broader organizational goals.
• Manage and oversee budgets for Case Management, ensuring financial targets and project milestones are achieved.
• Communicate transformation goals and progress to senior leadership, ensuring alignment with the organization’s strategic vision.
• Establishment and maintenance of a high performing outsourced medical evaluation function.
• Directing the medical evaluation strategy ensuring a consistent, scientifically robust approach embedded in CSL’s signal detection framework.

Requirements

• Bachelor's Degree in a relevant scientific or technical field (e.g., MS, PhD, PharmD) preferred.
• 15+ years in leading multi-year transformation projects, including outsourcing and organizational redesign within PV operations.
• Profound experience in vendor oversight and management applying innovative approaches to achieve case management excellence
• Demonstrated expertise in implementing PV technology solutions, such as intake automation, safety databases, signal detection, literature screening, and risk management.
• Extensive experience in managing global teams and partners
• Hands-on experience in vendor management, including negotiating contracts and building large offshore vendor models.

Benefits

• Health insurance
• 401(k) matching
• Flexible work hours
• Paid time off
• Remote work options