Consultants - Noss Research Consulting LLC

Rebecca Noss

Owner/Founder

Global Pharmacovigilance Consultant with 27 years of solid experience in pharmaceuticals. Loves patient safety, extending the patient’s quality of life, do the best to try to save the patient’s life. Master of Science in Pharmacovigilance Pharmacoepidemiology from the Universitè de Bordeaux France. Strong medical background with extensive experience in safety assessment of SAEs and SUSARs, SAE management, PV KPIs, PV CRO oversight, risk management, active member in DSMB, safety signals assessments, call centers, specialty pharmacies, SDEAs, literature review, MedDRA coding, author of safety documents.

Joel

B.S. in Biology from Baylor University, Texas. With 35 years of experience as an FDA Investigator, conducted inspections across GMP, medical devices, biologics, and certified ORA BIMO. He served as a BIMO specialist for the Dallas District Office, specializing in GCP/GLP/GVP inspections. He has worked in various therapeutic areas and not limited to oncology, immunology, neurology, cardiovascular, dermatology, and metabolism.

Emma

MSc in Pharmacovigilance and Pharmacoepidemiology from the Universitè de Bordeaux France. Experienced Pharmacist with over 15 years in regulatory affairs, specializing in dossier reviews for modules 2, 3, and 5. She has audited over 200 facilities for GMP, GCP, and GLP compliance and is well-versed in regulatory submissions across the USA, Europe, Africa, Canada, and Australia.

Kishan

Master of Science: Regulatory Affairs and Compliance for Drugs, Medical Devices and Biologics from the Northeastern University Boston and

Master of Pharmacy: Pharmacology Gujarat Technological University. Certified Biomedical Auditor (ASQ), ISO 9001 Lead Auditor (BSI). Ardent pharmacovigilance and quality assurance professional with 15 years of experience. He specializes in pharmacovigilance auditing, FDA REMS audits, and risk-based audit planning. Kishan has extensive experience managing PV inspections, adverse event reporting, and preparing regulatory documents.

Navya

Master’s degree in Biotechnology, Harrisburg University of Science and Technology, Harrisburg PA. With over 10 years of experience in pharmacovigilance, maintenance of the Safety database, creates safety reports for all clinical studies, writes safety narratives, coding the adverse events and serious adverse events with MedDRA and Who-DD drug dictionary. Performs safety reporting through EudraVigilance via EV-Web, inspection readiness, management of PV mailbox, SAE reconciliation, unblinding subject information in safety database, DSUR and aggregate periodic safety reports.

Don

Bachelor of Science Journalism & Communications, University of Florida. Over 42 years’ experience in the pharmaceutical and clinical research industry. With over 42 years of experience in pharmaceutical research, expertise in all areas of GCP, vendor management, Regulatory affairs, development of quality systems, SOP writing, and overall process improvements. Extensive auditing REMS, Routine and Directed GCP audits, Scientific Misconduct and Pre-Qualification audits of Clinical Investigator Sites, Vendors (GLP & CROs), hospitals, and Sponsors.

Karrin

Master’s degree in Public Health Community Health/Preventative Medicine University of Tennessee. Pharmacovigilance professional with 15 years of experience in strategic safety planning for investigational and market products, global Adverse Event (AE) case processing and Serious Adverse Event (SAE) reporting (SUSAR and periodic reports), regulatory intelligence for clinical and post marketed products (also Device and combination), regulatory audit and inspection preparation and resolutions, development of SOPs, signal detection review, and safety data exchange agreements.

Christina

Registered nurse and Master of Medical Science in Drug Development from the University of New South Wales Australia
Graduated with Distinction. 24 years in biopharma operations & leadership, driven by the pursuit of excellence for improved patient outcomes. Strong experience in Pharmacovigilance, Licensing, Medical Information (MI) & Quality Management Systems (QMS) with operational agility; blending strong functional expertise with a strategic, pragmatic, customer & patient centric approach.