Susan Augello-Vaisey, MS
Written by Administrator
Thursday, 13 May 2010 03:37
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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 plans on time and within budget.

Susan's experience also includes managing the Medical Affairs staff; safety profiling of marketed products; use of technical solutions for document management; medical information, 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 successful 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, Part 11 compliant software selection and implementation, CRA training, disease state training, and Medical Affairs planning for small Pharma. Susan conducts customized GCP, pharmacovigilance, and medical information training on site.

In 2008, Susan founded Pharma Consulting Solutions where she and a network of highly experienced consultants provide an array of services in the Rx, OTC, pharmaceutical, and dietary supplement industries including: pharmacovigilance, medical information, product quality complaint management, medical evaluation, and MedDRA coding and review; FDA and international regulatory submissions and product management, IND & NDA submission support, orphan drug applications; GCP/GMP/GLP/GPvP planning and auditing; clinical protocol writing and review, medical monitoring, study report writing, statistical analysis, and ISS and ISE development. The company is multi-lingual and caters to clients world-wide in particular in the US, Canada, India, and South America.
Last Updated ( Wednesday, 09 February 2011 17:44 )