Description
PROFILE International work experience in Pharmacovigilance, Clinical Trials, Pharmaceutical Sales and Regulatory Affairs encompassing Phase I experimental trials through post marketing. Experimental: Drug Safety Surveillance and Adverse Drug Event (AE) reporting for Clinical Trials conducted by the National Institutes of Health (NIH). National Cancer Institute - 7 years. National Institute of Allergy and Infectious Diseases - 4 years. Post marketing: Drug Safety Surveillance and AE reporting for Food and Drug Administration (FDA). FDA Adverse Events Reporting Programs Support (AERPS) - 4 years.
Accomplishments
Highlights:
Keywords
- Quality Assurance
- Quality Control
- Oracle Database
- Pharmacovigilance
- Drug Safety
- Major pharmaceutical company experience
- Contracts for National Institutes of Health
- Oncology
- MedDRA Coding
- Advanced Microsoft Office
- Drug Safety Reporting to FDA
- Rockville Bethesda Gaithersburg
- Database Reconciliation
- HIV AIDS
- SAE Serious Adverse Event Reporting
- Exceptional Communications skills
- Exceptional Presentation Skills
- IRB
- CRO
- Human Research Protection
- Study Protocol Review
- Safety Data Management Plan
