02.09.2026 aktualisiert
100 % verfügbar
Senior Pharmacovigilance Executive | EU/UK QPPV | Global Patient Safety & PV Operations Leader
Limburg-Staffel, Deutschland
Nur Remote
Pharmacist (Christian-Albrechts-University Kiel, Germany)Über mich
Pharmacist and senior pharmacovigilance executive with 25+ years of experience across pharmaceutical companies, CROs and pharmacovigilance service providers. Proven track record in global patient safety operations, GVP compliance, process optimization, leadership of international teams.
Skills
Patientensicherheit
Global Pharmacovigilance and Patient Safety Leadership
Over 25 years of experience leading international pharmacovigilance and patient safety organizations, including teams of 70+ employees across multiple sites, with full accountability for strategy, governance, operations and organizational development.
EU/UK QPPV Responsibilities and GVP Compliance
Extensive track record serving as EU QPPV and UK QPPV for multiple clients and organizations, providing pharmacovigilance system oversight, regulatory compliance leadership, PSMF governance and senior safety governance in line with GVP requirements.
Inspection Readiness and Regulatory Authority Preparation
Proven expertise in leading and supporting GVP/PV mock inspections, inspection readiness programs, controlled document reviews, regulatory gap assessments and story-line preparation for regulatory authority inspections.
PV Operations, Case Management and Aggregate Safety Reporting
Comprehensive operational expertise covering case management, aggregate safety reporting (DSUR, PSUR/PBRER, PADER, ACO), signal management, literature review, safety writing and QPPV services across global pharmaceutical and CRO environments.
Risk Management Plans and Benefit-Risk Evaluation
Director-level oversight for Risk Management Plans, EU Risk Management Plans, benefit-risk evaluation and safety governance, including preparation and review of Pharmacovigilance System Master Files.
Shared Service Center Build-up and Operating Model Design
Hands-on experience establishing pharmacovigilance shared service centers, QPPV office operating models and customer success management functions from concept to full implementation, including organizational design and team structure.
Process Optimization, Automation and AI Enablement
Introduction of process automation, Smartsheet-based project controlling toolkits, AI-enabled approaches and data foundations to improve execution quality, transparency and operational efficiency.
Budget Management, KPIs and Operational Performance Control
Management of department budgets of up to 10 million euros annually, including KPI-based planning, resource control and performance monitoring across international teams.
Pharmacogenomics and Personalized Medicine
Deep knowledge in pharmacogenomics, personalized medicine and safety evaluation methodologies, including chairing pharmacogenomics working groups, delivering international presentations and contributing to scientific publications on PGx integration into PV and risk management.
Strategic PV Consulting and Business Development
Customer-facing consulting expertise including bid defense support, proposal budgets, business development tools, fact sheets, executive presentations and high-quality client deliverables for pharmaceutical and life sciences clients.
Over 25 years of experience leading international pharmacovigilance and patient safety organizations, including teams of 70+ employees across multiple sites, with full accountability for strategy, governance, operations and organizational development.
EU/UK QPPV Responsibilities and GVP Compliance
Extensive track record serving as EU QPPV and UK QPPV for multiple clients and organizations, providing pharmacovigilance system oversight, regulatory compliance leadership, PSMF governance and senior safety governance in line with GVP requirements.
Inspection Readiness and Regulatory Authority Preparation
Proven expertise in leading and supporting GVP/PV mock inspections, inspection readiness programs, controlled document reviews, regulatory gap assessments and story-line preparation for regulatory authority inspections.
PV Operations, Case Management and Aggregate Safety Reporting
Comprehensive operational expertise covering case management, aggregate safety reporting (DSUR, PSUR/PBRER, PADER, ACO), signal management, literature review, safety writing and QPPV services across global pharmaceutical and CRO environments.
Risk Management Plans and Benefit-Risk Evaluation
Director-level oversight for Risk Management Plans, EU Risk Management Plans, benefit-risk evaluation and safety governance, including preparation and review of Pharmacovigilance System Master Files.
Shared Service Center Build-up and Operating Model Design
Hands-on experience establishing pharmacovigilance shared service centers, QPPV office operating models and customer success management functions from concept to full implementation, including organizational design and team structure.
Process Optimization, Automation and AI Enablement
Introduction of process automation, Smartsheet-based project controlling toolkits, AI-enabled approaches and data foundations to improve execution quality, transparency and operational efficiency.
Budget Management, KPIs and Operational Performance Control
Management of department budgets of up to 10 million euros annually, including KPI-based planning, resource control and performance monitoring across international teams.
Pharmacogenomics and Personalized Medicine
Deep knowledge in pharmacogenomics, personalized medicine and safety evaluation methodologies, including chairing pharmacogenomics working groups, delivering international presentations and contributing to scientific publications on PGx integration into PV and risk management.
Strategic PV Consulting and Business Development
Customer-facing consulting expertise including bid defense support, proposal budgets, business development tools, fact sheets, executive presentations and high-quality client deliverables for pharmaceutical and life sciences clients.
Erfahrung
Berufserfahrungmehr als 10 Jahre
Freelancer seit2026
Sprachen
DeutschMutterspracheEnglischverhandlungssicher
Projekthistorie
Built and led the Pharmacovigilance Customer Success Management function from inception, establishing team structure, ways of working and operational priorities. Served as EU QPPV and UK QPPV for two clients. Directed a USD 2 million end-to-end pharmacovigilance project and introduced a Smartsheet-based project controlling toolkit. Owned team development, operational performance management, KPI oversight and department budget responsibility.
Led global Medicovigilance, Pharmacovigilance and Audit functions with responsibility for strategy, governance, operations and organizational development. Established a pharmacovigilance shared service center in Timisoara, Romania. Held EU QPPV and UK QPPV responsibilities from 2022 to 2023. Managed global accountability for Medicovigilance, Pharmacovigilance, supplier audits and PV audits, including team development, resource planning and department budget responsibility.
Provided senior pharmacovigilance consulting and interim management support to pharmaceutical and life sciences clients. Delivered global PV services across the full operating model, including system governance, compliance support and operational execution. Advised clients on pharmacogenomics, inspection readiness and pharmacovigilance mock inspection preparation.