Susan Augello-Vaisey, MS
Susan has made her career working first in big Pharma and then 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 FDA audits; responding to GMP observations in cosmetics; extensive medical writing; SOP development (medical and clinical); hiring and managing Medical Affairs and Medical Science Liaison 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 clinical trial operations programs for emerging companies including staffing, process and procedures, data base implementation, and statistical and database management.
She has made presentations on GPvP, disease state training, bringing in Part 11 compliant software systems, CRA and sales force training, and Medical Affairs planning for small Pharma. Susan conducts customized GCP, pharmacovigilance, and medical information training on site.
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, cosmetic, 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.
Nirmalya Banerjee MD, MHSA
Nirmalya has a broad background in clinical research conducting Phase I-IV studies in oncology, immunology, and neurology. He has managed studies both as a Principle Investigator and as a Medical Monitor. More recently, he has provided drug safety support and the overseeing physician at three of the largest US pharmaceutical companies. This included compiling drug safety reports to US and global regulatory agencies. Some of his duties include reviewing and approving clinical sections in Clinical Trial Applications and Investigational New Drug applications along with oversight of CROs. In the Medical Science Liaison field, Nirmalya has conducted presentations through out his career to Key Opinion leaders, PBMs, Clinical Pathway companies and Payers. He has extensive knowledge in US Policy on Medical Liaisons, off-label requests and product promotion. He provides support for regulatory meetings and filings, medical review of advertising and promotional materials. He has been conducting Health Hazard Assessments and safety evaluations on finished products, reviewing adverse event coding, and approving expedited reports to FDA and international regulatory agencies. He routinely assesses seriousness and clinical significance for expedited reports and periodic reports.
Nirmalya has a BS in Biology and Chemistry from Southern University in Baton Rouge, LA and gained his Doctor of Medicine from Central American Health Sciences University in Belize. He finished his medical training at the University of Illinois Scholl of Medicine and in licensed to practice in Illinois and New York. He has continued his formal education with degrees in Master of Health Science from St. Joseph’s College in Maine and an MBA in Pharmaceutical and Health Management from St Joseph’s University in PA.
S. Lee Schroeder, BA
Lee has been a healthcare service professional who has spent her career serving patients, physicians and other healthcare professionals as a community health educator, medical call center manager and intake specialist, and in collection and assessment of patient medical records. In these various roles, Lee has developed a strong skill set in case management and risk assessment. She has 12 years of experience providing medical information at various levels, and relationship building with clients. She has held various positions in regulated industries to serve “in the trenches” and in leadership positions.
Lee’s broad scope of experience has made her an expert in high volume call center management, case triage, and customer relations. Due to her excellent relationship building she has a high rate of follow through on resolution of adverse events. She takes pride in providing customers with the perfect service experience by assisting them with their needs while obtaining the necessary information for company compliance with regulations creating positive results for the customer and the company.
Lee’s history has led her to the position of Call Center Manager in PCS where she is adept at analyzing problem situations in a calm and professional manner. She manages the phone system and develops responses to frequently asked questions. She oversees the intake of adverse events, product quality complaints and medical inquiries.
Lee has a B.A in Interdisciplinary Social Sciences from the University of South Florida and recently attained certification in “Consumer Experience Certification Specialist” by Customer Experience Professionals Association (CXPA) in 2016.