PV Operations Transformation Lead

Position Summary
The Process Improvement Lead will drive strategic initiatives to enhance pharmacovigilance (PV) Operations, ensuring operational excellence, regulatory compliance, and data integrity. This role will focus on transforming PV workflows through Lean Six Sigma methodologies, partnering with internal stakeholders, safety vendors, and global teams to deliver measurable improvements in quality, efficiency, and compliance.
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Key Responsibilities:

• Strategically support PV Operations management in planning and implementing Lean Six Sigma (LSS) methodologies to drive operational excellence.

• Lead transformation initiatives across PV Operations, including adverse event reporting, case handling, aggregate reporting, literature surveillance, and safety systems.

• Develop and execute long-term process improvement roadmaps aligned with safety database capabilities and regulatory expectations.

• Identify and lead key improvement projects that enhance quality, reduce costs, and improve productivity.

• Apply LSS tools (e.g., DMAIC, Kaizen, Value Stream Mapping) to streamline processes and standardize SOPs, process maps, and best practices to ensure GVP/GCP compliance.

• Define, monitor, and report KPIs and quality metrics; develop dashboards to track performance trends and identify improvement opportunities.

• Recommend and support automation and technology enhancements to optimize PV operations.

• Champion a culture of continuous improvement and serve as a change agent to challenge existing processes.

• Facilitate training sessions and workshops to build Lean Six Sigma capability, including coaching and certifying "belted" associates.

• Collaborate with global PV teams, regulatory affairs, clinical operations, and external vendors to harmonize processes and ensure audit readiness.

• Support CAPA implementation using Six Sigma problem-solving frameworks.

• Provide strategic input and influence to senior leadership for PV transformation planning and execution.

• Communicate data-driven insights to support improvement opportunities and stakeholder engagement.

• Ensure alignment with organizational mission, standards, and guidelines through coordinated leadership support.

• Perform other duties as assigned to support the organization's vision, mission, and values.
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Qualifications & Experience
Required:

• Bachelor's degree in life sciences, pharmacy, nursing, or related field.

• 8 years of experience in global pharmacovigilance operations.

• Proven success in leading process improvement initiatives in pharmaceutical or biotech settings.

• Lean Six Sigma Green Belt (minimum); Black Belt preferred.

• Strong understanding of global PV regulations (GVP, FDA, EMA, ICH).
Preferred:

• Experience with safety databases (e.g., LSMV, Veeva Vault Safety).

• Advanced skills in data analysis and visualization (Excel, Power BI, Tableau).

• Demonstrated ability to lead cross-functional teams and manage complex projects.
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Key Competencies

• Strategic thinking and analytical problem-solving.

• Strong facilitation and communication skills.

• High attention to detail and quality orientation.

• Ability to manage multiple priorities and drive results.

• Influencing and negotiation skills across diverse stakeholder groups.
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Performance Measures

• Reduction in cycle times for PV Operations and oversight activities.

• Improvement in quality metrics and regulatory compliance scores.

• Successful execution of Lean Six Sigma projects.

• Increased stakeholder satisfaction and process adoption.

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