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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...
Tags for this Online Resume: 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
SUMMARY * Medical degree with over 25 year experience in clinical and drug safety surveillance setting within the pharmaceutical and Biopharmaceutical industry (Example: Amgen, Alza Corporation, Idec, Biogen Idec, Elan, Genentech, Roche, Sharing AG, Wyeth, Élan Pharmaceuticals, Actelion Pharmaceuticals) * Advance knowledge of US and international Safety regulations and Safety assessment of Marketed and Investigational drugs...