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Pharmacovigilance
Pharmacovigilance professional with 18 years’ experience developing and reengineering PV departments in small to medium sized pharmaceutical/biotechnology companies. Operational expertise includes the evaluation, development and implementation of PV processes and infrastructure, vendor management, SOP development and revision, CAPA management, compliance…
Food Safety, Nutrition, Regulatory Matters, Health and Wellness, and Business Strategy
With experience in the public and private sectors, Expert provides advice and guidance on a wide range of topics. She has senior experience in health and wellness, business strategy, product development, regulatory compliance, food safety, quality systems management, supply chain,…
Forensic DNA Analyst
Expert founded his company in 1993, a forensic scientist who specializes in the analysis of DNA and the use of insects in legal investigations. Expert has evaluated and provided expert guidance for more than four hundred criminal and paternity cases,…
Consumer Product Safety, Regulatory and Retail Compliance, Quality Assurance
Expert is a consumer product (non-food) safety, regulatory and retail compliance, quality assurance and control, 3rd party lab testing / inspection / auditing, CPSC (Consumer Product Safety Commission), CPSIA (Consumer Product Safety Improvement Act), Federal / State / Local compliance…
Occupational Safety and Health
All regulations pertaining to offshore and onshore oil and gas drilling. OSHA reporting and record-keeping. Expert has represented major clients in the petrochemical industry such as Shell, BP, and Chevron. He has HSE management experience as Lead HSE Tech. for…
Pharma/Biotech Market Access, Pricing & Reimbursement, Business Development Europe and Latin America
Pharmaceutical executive with 17+ yrs. experience in international, corporate and local/regional roles at leading pharmaceutical companies in Europe and Latin America. Strong experience in general management, business development and licensing, alliance management, project and transition leadership, marketing and sales, strategic…
Hepatology Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis (NASH) Liver Disease, Pharmacovigilance, Drug Development- Drug-Induced Liver Injury Hepatotoxicity
Expert has been a hepatologist since 1988. She was in a solo practice devoted to treating and evaluating patients with liver disease until 2009 at which time she became Director of Hepatology. During that time she served as a consultant…
Banking & Risk Management
Banking professional with a unique combination of skills offering 30 years of experience in the areas of Mergers and Acquisition, Risk Management, Bank Operations, Internal Audit, Regulatory Compliance, Credit Operations, Retail Products and Cost Reduction Strategies. Proven track record managing…
BioPharmaceutical Commercialization
New product planning, business development, and marketing professional with transactional, launch, and expert witness experience. Expertise in new product commercialization, licensing, valuations, deal structure, strategic brand planning, long range forecasting, pricing & reimbursement, HEOR strategies, payor communications, tactical program implementation,…
Incident Investigation, Risk Management, Safety Management
Work-site evaluations, compliance audits, hazard assessments, facility-design reviews, Safety Program evaluations and training programs. Risk Management Consulting · Business Consulting · HR Consulting · Environmental Consulting. The “No Blame Safety Strategy” liberates Organizations as it fosters employee loyalty and critical…