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
With 35 years of experience as an FDA Investigator, Joel has conducted inspections across GMP, medical devices, biologics, and BIMO. He served as a BIMO specialist for the Dallas District Office, specializing in GCP/GLP/GVP inspections. Joel has worked across various therapeutic areas, including oncology, immunology, neurology, cardiovascular, dermatology, and metabolism.
Emma
Emma is an experienced pharmacist with over 15 years in regulatory affairs, specializing in dossier reviews for modules 2, 3, and 5. She has inspected 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
Kishan is a 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
With over 10 years of experience in pharmacovigilance, Navya leads clinical safety teams and manages safety database maintenance. She specializes in adverse event reporting, writing SOPs, and preparing safety reports for clinical studies. Navya also handles EudraVigilance reporting and audit preparation.
Don
With over 42 years of experience in pharmaceutical research, Don has expertise in GCP, vendor management, SOP development, and auditing. He has conducted REMS, GCP, and scientific misconduct audits and is proficient in eTMF, CTMS, and regulatory affairs.
Karrin
Karrin has 15 years of experience in pharmacovigilance, specializing in strategic safety planning, adverse event case processing, and regulatory audits. She is experienced in developing SOPs, signal detection, and risk management, and works with clinical and post-marketing products.
Christina
Christina has 24 years of experience in biopharma operations, specializing in pharmacovigilance, medical information, and quality management systems. She excels in process improvement, operational leadership, and leading multicultural teams in licensing, acquisitions, and patient outcome initiatives.