Head of Pharmacovigilance

CSL

21d•Hybrid

About The Position

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. Could you be our next Head of Pharmacovigilance? The job is in our King of Prussia, PA, Maidenhead UK or Zurich Switzerland office. This is a hybrid position and is onsite three days a week. You will be a strategic leader that ensures a lean, agile, and cost-efficient organization that delivers the highest standards of patient safety, while maintaining strict compliance with global regulations. The Head of Pharmacovigilance will develop and implement innovative case management strategies across the Enterprise ensuring compliance with regulatory obligations and scientific excellence. The incumbent will spearhead and oversee strategic outsourcing initiatives, organizational redesign, and implement automation to enhance operational efficiency, data quality, and cost savings.

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.

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.
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