Karl Gallegos, MD, MPH, CPI is a recognized expert in Pharmacovigilance, Risk Assessment, Risk Management, and Risk Communication. He has over 20 years experience working in the biotechnology and pharmaceutical industry. Dr. Gallegos has had a virtually unique experience working as a consultant for more than 40 pharmaceutical, biotechnology, and medical device companies. He has provided expert assistance in all activities related to pharmacovigilance and safety assessment of investigational and marketed drugs, biologicals and medical devices, including: evidence-based drug safety and risk management solutions; regulatory strategy, regulatory intelligence, and development of proactive pharmacovigilance and risk management plans; development of specialized drug safety database and safety registry initiatives; drug safety database system software selection, related implementation and development of SOPs, hosting services guidelines and work instructions for clinical safety and post marketing safety; critical enterprise wide RFP/ RFI development for electronic data capture, and pharmacovigilance system implementations including: identifying business requirements, technology solutions, in-source/out-source options, and review of best of breed (capability maturity model) offerings; preparation and oversight of regulatory safety reports and safety labelling; surveillance and clinical evaluation of individual and aggregate cases, for signal detection, label re-write and risk mitigation strategic activities; MedDRA implementation, including training in coding, retrieval, and labelling use; and auditing and development, evaluation, and enhancement of pharmacovigilance processes and work practices.

Dr. Gallegos received his undergraduate degree from Massachusetts Institute of Technology, and his medical degree from Harvard Medical School. He trained in General Surgery and Orthopedic Surgery at Columbia Presbyterian Hospital, and did a fellowship in Orthopedics and Rheumatology Research at the Hospital for Special Surgery. He has also studied epidemiology at Emory University in Atlanta and received an MPH in Public Health from University of North Carolina, Chapel Hill. Prior to entering industry, he spent 10 years in “wet-bench” and epidemiologic research, and practiced addiction medicine. Dr Gallegos has served on numerous committees and held office in several professional organizations. He has been a frequent speaker and contributor in national conferences, is widely published, and is the recipient of numerous awards.