Head of Pharmacovigilance Operations
CSL
full-time
Posted on:
Location Type: Hybrid
Location: King of Prussia • Pennsylvania • United States
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Job Level
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
case processingregulatory complianceoperational benchmarkingautomationcost-saving strategiesperformance metricsvendor managementrisk managementsignal detectionliterature screening
Soft Skills
leadershipcommunicationorganizational redesigninnovationcollaborationstrategic visionadaptabilityemployee retrainingcontinuous improvementrelationship building
Certifications
Bachelor's DegreeMSPhDPharmD