Profile * Highly accomplished healthcare professional with diverse bio-pharmaceutical and consumer product global pharmacovigilance/safety, surveillance, risk management, quality compliance and quality assurance experience * Global pharmacovigilance knowledge management lead and subject matter expert with strong medical writing, project management and off-shore vendor management experience * Excellent global drug safety /regulatory-safety competency * Exceptional ability to motivate and direct others within a global matrix environment * Flexible and resourceful with strong multi-tasking skills Summary of Qualifications * Twelve years' experience with aggregate data analysis, surveillance, scientific literature research and medical writing for major global pharmaceutical company * Twelve years' experience with global Regulatory Authority inspections and requests

Highlights:

• Compliance
• Regulatory Reporting
• Data Analysis
• Medical
• Quality
• Management
• Pharmaceutical
• Audit
• Computer Aided Software Engineering
• Health Care Industry