Susan Augello-Vaisey, MS
Susan has made her career working in big Pharma and at newly emerging pharmaceutical companies developing the processes and procedures for clinical trials and medical affairs functions from the pre-approval stage through product launches and post-marketing support. To a large degree, this involved assessing the needs of the organizations, determining the best solutions for high levels of patient safety, regulatory compliance, and minimal risk and expense for the company, and ultimately implementing the plan on time and within budget.
Susan’s experience also includes managing the Medical Affairs staff; safety profiling of marketing products; use of technical solutions for document management; pharmacovigilance and complaint handling software selection, installation and testing (IQ, OQ, PQ); due diligence activities for potential product acquisitions; and, GCP auditing of clinical trials.
Susan has built a clinical trial operations program for an emerging company including staffing, process and procedures, data base implementation, and statistical management.
She has made presentations on GPvP, disease state training, bringing in Part 11 compliant software systems, CRA Training Review, and Medical Affairs planning for small Pharma. Susan conducts customized GCP, pharmacovigilance, and medical information training on site.
Most recently, Susan founded Pharma Consulting Solutions where she and other highly experienced consultants provide an array of services in the pharmaceutical and device industries including: pharmacovigilance, medical information, product quality complaint management; FDA and international regulatory affairs drug , device, and dietary supplement applications, and medical monitoring of clinical studies, IND & NDA submission support, GCP/GMP/GPvP planning and auditing; orphan drug applications; and MedDRA coding and review.