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Browse Online Resumes by Occupation
Science & Biotech Online Resumes
Clinical Pharmacovigilance/Drug Safety
PROFILE 7 QUALIFICATIONS & TRAINING
Tags for this Online Resume: Compliance, Extensible Markup Language (XML), Management, Medical, Microsoft Excel, Microsoft PowerPoint, Microsoft Word, Quality, Quality Assurance, Time Management
Clinical Pharmacovigilance/Drug Safety - 15 Years of Experience - Near 27502
Tags for this Online Resume: Pharmacovigilance, Drug safety
Clinical Research - 9 Years of Experience - Near 38654
Career Summary Pharmacovigilance Director of consumer care division with an in-depth knowledge of Food and Drug Administration (FDA) regulations governing the reporting of adverse events and experienced in a GMP, compliance-driven environment. An articulate and positive communicator with proven effective management of staff, workload, vendors and associated processes to maintain exceptional quality, consistency and complian...
Tags for this Online Resume: Documentation, Management, Regulatory Affairs, Compliance, Integrate, Outsourcing, Quality, Risk Management, Triage, Audit, pharmaceutical, regulatory, Drug safety, clinical trials, research
Clinical Pharmacovigilance/Drug Safety - 10 Years of Experience - Near 19440
Summary Clinical Scientist/Clinical Data Analyst/Clinical Data Management/Project Coordinator/GLP auditor/Research Biologist with over 15 years experience in the pharmaceutical industry. Authored/QC review of protocols, protocol amendments, protocol clarification letters, informed consent forms, risk language, periodic safety reports (PSUR, DSUR, QSR), investigator brochures, medical monitoring plans, clinical SAE narrative...
Tags for this Online Resume: Protocol, Oncology, Audit, Monitoring, Critical Care - Neurology, ICH, Neurology, Quality Assurance, Test, Data Quality
Clinical Pharmacovigilance/Drug Safety - 20 Years of Experience - Near 95117
CAREER SUMMARY * Senior, seasoned pharmaceutical R&D professional with strong administrative, strategic & scientific planning, and coordination/execution skills, gained through 27 years of industrial experience in leading CMC technical development function (Pharmaceutics & Analytical), and leading global development & regulatory filings for NMEs (small molecule and biologics / mAb), and 505 (b) (2) products strong expertise...
Tags for this Online Resume: CMC, Product Development, Regulatory Affairs, Good Manufacturing Practices, Management, Project Management, Technical Lead, DP, Product Development, Supply Chain, Technical Operations
Clinical Pharmacovigilance/Drug Safety
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...
Tags for this Online Resume: Training, Data Entry, Coding, Policies and Procedures, Clinical Research, Data Management, Immunology, Management, Oncology, Query
Clinical Pharmacovigilance/Drug Safety - 20 Years of Experience - Near 75025
SUMMARY Highly accomplished professional with a diverse cross industry background and experience in critical analytical roles within top tier companies in the Telecom, Financial, Utility Energy, Pharmaceutical and Consulting Industry. A seasoned leader with demonstrated track record of positively influencing corporate performance by skillful deployment of enhanced and complex analytical solutions and thought leadership, whi...
Tags for this Online Resume: Predictive Modeling, Demand Forecasting, SAS, Marketing Budget Development, Strategic Planning, SQL, Data Mining, Global Delivery Model, Statistical Models, Hadoop, Risk Management, Scorecard Development, Business Intelligence, Statistical Consulting, Marketing Analytics
Clinical Pharmacovigilance/Drug Safety - 17 Years of Experience
Summary: Over 16 years of Drug Safety experience that includes Global Drug Safety project management in Clinical Research Organization and Sponsor (Pharmaceutical) environments. Experienced clinical trial and post-marketing studies. Participated in stand-alone and full service studies as Global Drug Safety/Pharmacovigilance Lead in addition to mentoring and managing a team of junior drug safety associates.
Tags for this Online Resume: Oncology, Hepatitis, Query, Cardiovascular, Documentation, Infectious Diseases, Quality, Quality Assurance, Quality Control, Data Entry
Clinical Pharmacovigilance/Drug Safety
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 /re...
Tags for this Online Resume: Compliance, Regulatory Reporting, Data Analysis, Medical, Quality, Management, Pharmaceutical, Audit, Computer Aided Software Engineering, Health Care Industry
Clinical Pharmacovigilance/Drug Safety
Career Summary Biotechnology Manager/consultant, I consistently managed several programs and project portfolios while tightening cost controls through effective management of resources. This led to increasing yearly profits for the company exceeding 100+% while impacting lives. As a research fellow at the NIH/NCI, I devoted time and energy in excess of required working hours leading & managing significant parts of a ground ...
Tags for this Online Resume: Diagnostics, Biotechnology, Clinical Research, Distribution, Engineering, Good Clinical Practices, HIV, Program Manager, Protocol, Public Health
Clinical Pharmacovigilance/Drug Safety
A strategic new product development leader with over twenty years of accomplishments in a cross functional role spanning multiple therapeutic areas in small and multinational companies with continued success in innovator specialty and drug-device product formulation CMC strategic portfolio/program management/planning IP mission critical decision making phase appropriate product development NIH grant writing regulatory clini...
Tags for this Online Resume: Business Development, Licensing, Project Leader, Project Management, Management, Pharmaceutical, Diagnostics, Leadership, Planning, Program Management
Pharmaceutical Scientist
SUMMARY * Scientific Leadership-Pharmaceutics. Wealth of experience (>25 years) in delivering impactful products to the market through Formulation/Process development (solids, liquids, and parenteral dosage forms) and Analytical development. Key example: Lexapro marketed by Forest. * Organizational Leadership and Mentor. Scientific organization management that focused on learning and delivering results. Underlying philosoph...
Tags for this Online Resume: Management, Business Development, Documentation, MOS, Pharmaceutical, Due Diligence, Manufacturing, Packaging, Process Improvement, Quality
