SUMMARY: International work experience in Pharmacovigilance, Clinical Trials, Pharmaceutical Sales and Regulatory Affairs encompassing Phase I experimental trials through post marketing safety reporting for the National Institutes of Health and for major pharmaceutical companies. Accomplishments include: Work Instruction Manual on Data Reconciliation for Astrazeneca. Led a team of six in writing the Work Instruction Manual on Data Reconciliation for Data Management (DM) personnel and newly participating Clinical Research Organizations (CROs) for all AstraZeneca studies encompassing four therapeutic product areas and over 80 clinical trial studies. * Merger of Safety Departments of Medimmune and Astrazeneca. Created training materials for Clinical Trials Teams for the merger of two Safety teams from MedImmune and AstraZeneca to ensure consistency amongst the two departments in safety reporting to regulatory agencies. * Outsourcing of Pharmacovigilance Department for Bristol Myers Squibb. Led the staff training effort for outsourcing project of entire pharmacovigilance drug safety department for Bristol Myers Squibb. * First Ever Web Based Medical Dictionary for Regulatory Affairs (MedDRA) Commercial Training Product. Designed website interface for MedDRA Training product and coordinated launch of the first ever commercial training product teaching MedDRA coding. * Product Launch of Buprenorphine for Reckitt Benckiser. Conducted, organized and managed physician presentations for the product launch of Buprenorphine, a new treatment for opiate addiction. * Pioneering International Trial for Interleukin 2 in the Treatment of HIV/AIDS. Responsible for funding allocation and site accrual for a four year pioneering international clinical trial of Interleukin-2 involving 30 countries. Accomplishments include: Work Instruction Manual on Data Reconciliation for Astrazeneca. Led a team of six in writing the Work Instruction Manual on Data Reconciliation for Data Management (DM) personnel and newly participating Clinical Research Organizations (CROs) for all AstraZeneca studies encompassing four therapeutic product areas and over 80 clinical trial studies. * Merger of Safety Departments of Medimmune and Astrazeneca. Created training materials for Clinical Trials Teams for the merger of two Safety teams from MedImmune and AstraZeneca to ensure consistency amongst the two departments in safety reporting to regulatory agencies. * Outsourcing of Pharmacovigilance Department for Bristol Myers Squibb. Led the staff training effort for outsourcing project of entire pharmacovigilance drug safety department for Bristol Myers Squibb. * First Ever Web Based Medical Dictionary for Regulatory Affairs (MedDRA) Commercial Training Product. Designed website interface for MedDRA Training product and coordinated launch of the first ever commercial training product teaching MedDRA coding. * Product Launch of Buprenorphine for Reckitt Benckiser. Conducted, organized and managed physician presentations for the product launch of Buprenorphine, a new treatment for opiate addiction. * Pioneering International Trial for Interleukin 2 in the Treatment of HIV/AIDS. Responsible for funding allocation and site accrual for a four year pioneering international clinical trial of Interleukin-2 involving 30 countries.

Highlights:

• Team Lead
• MedDRA
• RN
• Acquired Immune Deficiency Syndrome (AIDS)
• oncology
• Drug Safety Monitoring
• Quality Assurance
• Quality Control
• Clinical Research Support
• Data Management
• Pharmacovigilance
• FDA Reporting
• IRB
• International experience
• Product Launch