Head of Pharmacovigilance Operations

CSL is transforming its R&D organization to accelerate innovation and create greater impact for patients. With a streamlined, project‑led structure and a focus on collaboration, we’re building a future‑ready team that excels in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.

Head of Pharmacovigilance Operations – This role is located in the King of Prussia, PA, Maidenhead UK or Zurich Switzerland office. This hybrid position requires onsite presence three days a week.

Case Management Responsibilities

• 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.

Business Transformation

• 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.

Intake & Triage

• 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.

Vendor Oversight And Management

• 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.

Cross-Functional Collaboration

• 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.

Medical Evaluation

• Establish and maintain a high‑performing outsourced medical evaluation function.
• Direct the medical evaluation strategy ensuring a consistent, scientifically robust approach embedded in CSL’s signal detection framework.

Job Qualifications And Experience 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.

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit

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