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Pharmacovigilance Specialist
Expert is a pharmacy professional specializing in pharmaceutical services and pharmacovigilance. Pharmacovigilance, also known as drug safety, is the pharmaceutical science relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects with pharmaceutical products. He has more than…
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…
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…
Clinical Development, Safety Reviews, Pharmacovigilance, Pharmacoeconomics
• Employer for preparation for an FDA Advisory Committee regarding review of an NDA. • Design and implementation of Phase I-IV clinical studies • Employer to many large pharmaceutical companies • Employer to Biotechnology companies and CROs • Medical safety…
Pharmacology; Infusion, Strategy, Short and Long Term Solutions, Client Challenges
Expert, as a clinical manager, is very dedicated to delivering quality outcomes for patients with demonstrated accomplishments in leading the strategy and development of mission-critical healthcare administration and solutions within the ever-changing healthcare institutions, each day is filled with producing…
Detection of Adverse Drug Reactions with a Specialized Focus on Neuropsychiatric Adverse Reactions
Expert is a board-certified psychiatrist who runs a private practice that specializes in the identification and treatment of adverse reactions of neuropsychiatric medications. He has over 7 years of experience as a clinical psychiatrist, and has been engaged in drug…
Nephrology and Managed Care
Experience: Chief Medical Officer, Chief Health Officer, Chief Value Officer, Value Creation, Medical Operations, Healthcare Strategy, Complex Medical Conditions, Total Cost of Care, Affordability, Real-World Value Evidence and Outcomes Research, Medical Devices, Healthcare technology, Pricing and Market Access, Value Based…
Cardiovascular Safety
Expert is a cardiologist with over two decades of experience in treating patients and clinical research in academia. He is working in the pharmaceutical industry for 15 years in drug safety; pharmacovigilance. He worked in many therapeutic areas throughout his…
in vitro diagnostic assay designing, development and troubleshooting
Experthas developed and participated in assay development and troubleshooting for variety of target molecules with special skill in development of ELISA on different platforms (spectroscopy, luminescence and electrochemical). He has also acquired very good grasp on nanoparticles based rapid assays.…
Clinical Research, Clinical Trials, Drug Development, Drug Safety, Patient Consenting Process
Experienced clinical research professional with a demonstrated global leadership in the pharmaceutical and medical device industry. Global organization and oversight of clinical research, QA and regulatory strategies. Leadership in new business development (medical device and medical software development quality management,…