Jan Holzer
Head of Safety Systems, Data Management and Safety Operations @Vantive
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WORK HISTORY
Head of Safety Systems, Data Management and Safety Operations @Vantive
Directly responsible for the strategic oversight of Global Safety Operations, Safety Systems, and Data ManagementGlobal Operations: Lead daily safety operations, including global literature search, quality control, and ICSR submissions to health authorities and partners worldwide.Systems & Data Strategy: Oversee the Global Safety Database, defining data conventions and database solutions to ensure accurate global data analysis and reporting.Vendor & Technology Management: Manage global IT and safety database vendors, overseeing contract negotiations, KPI performance, and the translation of business needs into system requirements.Compliance & Audit Readiness: Drive global operational excellence and serve as a Subject Matter Expert for regulatory inspections and internal audits.Team Leadership: Direct a global team of PV professionals, focusing on recruitment, performance management, and the development of safety staff.
EDUCATION
Fachhochschule Giessen-Friedberg
Master of Arts, Technische Redaktion multimediale Dokumentation
Technische Hochschule Mittelhessen
Bachelor of Science, Informatik
SKILLS
ABOUT JAN HOLZER
Highly accomplished and results-driven Pharmacovigilance Systems leader with over 15 years of experience in the Pharmaceutical Industry, including 10+ years in Pharmacovigilance.My expertise lies in spearheading complex global projects, driving digital transformation, and optimizing operational efficiencies, consistently achieving significant cost savings (up to 25%). I am adept at leading cross-functional teams, navigating regulatory complexities, and leveraging innovative solutions, including AI, to enhance pharmacovigilance processes and ensure robust compliance.Key Accomplishments & Value:Pioneering Automation: Led the PV Intake Automation Project, projected to achieve 20% operational efficiency gains in case processing by integrating advanced AI capabilities, streamlining workflows, and significantly improving data quality.Cost Optimization: Orchestrated the consolidation of PV Systems managed service providers, generating substantial annual cost reductions and achieving over 25% savings in operational expenditures.Global Systems Leadership: Successfully led multiple complex global Argus upgrade and integration initiatives (e.g, E2B R3, FDA Combination Products, Argus-J), migrating vast datasets and ensuring continuous regulatory compliance for critical safety databases.Team & Innovation: Fostered high-performing teams, mentoring individuals to assume greater project responsibilities, and drove strategic innovation by integrating AI into Pharmacovigilance processes, including vendor qualification for future acquisitions.Core Competencies:Strategic Planning | Team Leadership & Development | Mentoring & Coaching | Stakeholder Management | Change Leadership | Digital Transformation | Innovation Management | Vendor Management | Safety Database Management | GxP Compliance | Regulatory Reporting | AI/Machine Learning (Impact on Business Strategy)| Process Optimization | Data Migration | Validation & Testing | CAPA & Deviation Management | Audit & Inspection Support.I am passionate about leveraging technology and strategic leadership to advance pharmacovigilance capabilities and ensure patient safety globally. Connect with me to discuss opportunities in PV innovation, digital transformation, or strategic system management.
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