Patient safety is first!  Pharmacovigilance driven by protecting patients through detecting and defining medication safety risks.

Noss Research Consulting LLC. is a global Pharmacovigilance ‘PV’ consulting business with twenty-five years of solid clinical research experience.

Consultants bring over 20+ years of professional experience. Excellence in providing safety operational strategy to product development teams, ensuring timely and high-quality execution of safety documents.

  • Strong medical background, Medical assessment of serious adverse events
  • Medical review of global Suspected Unexpected Serious Adverse Reaction reports (SUSARs)
  • Management of Pharmacovigilance Service Providers
  • Safety author of Protocols
  • Author of: PV SOPs, Protocols, ICFs, SMP, RMP, RSI, SAE form, Pregnancy form
  • Review and approval of safety documents
  • Pre-marketing and post-marketing PV services
  • PV Risk Assessment  
  • EudraVigilance  
  • PV Key Performance Indicators (KPIs)
  • EMA Good Pharmacovigilance Practices (GVP)
  • FDA REMS
  • Safety Data Exchange Agreement (SDEA)

Consultants highly experienced in GCP, GLP, GVP, GMP.

Routine and for-cause audits, regulatory mock inspections, SOP writing, global regulatory submissions experts and IT audits. Excellent organizational, management, leadership, and interpersonal skills. Prioritize and manage multiple assignments concurrently with exceptional attention to detail and meticulous follow-through, and highest quality

Rebecca

Rebecca

Global PV consultant with 25 years of pharmaceuticals experience. Master of Science in Pharmacovigilance and Pharmacoepidemiology from the University of Bordeaux.

Expertise in and not limited to: Oncology, Hematology, Vaccines, Rare Diseases, Cardiovascular, Gastroenterology, OB/GYN, Dermatology, Immunology, Pulmonary, Infectious Diseases, Endocrinology, Renal, Pre-term Infants, Consumer Health, and Chronic Hepatitis. My goal is to ensure patient safety is not compromised.

Joel

Joel

Former FDA Investigator that spanned for a period of 35 years. As a Certified ORA BIMO Investigator conducted GCP inspections of Sponsors, Clinical Investigators, CROs, IRBs, PV, and Non-clinical laboratories (GLPs). Also conducted drug GMP inspections. As a member of FDA's Foreign Inspection Cadre conducted international FDA inspections.

Since my retirement from the FDA in December 2018 I have been working as a GCP consultant specializing in FDA’s BIMO programs.  Have been extensively involved in the conduct of Sponsor mock inspections, clinical investigator audits, gap assessments, and pharmacovigilance mock inspections/audits, and FDA readiness projects such as conducting SME interviews. My goal is to ensure a firm passes an FDA inspection without having received an FDA 483

Emma

Emma

Pharmacist with over 15 years work experience in medicine regulation, regulatory systems strengthening and a MSc in Pharmacovigilance and Pharmacoepidemiology. Inspected over two hundred facilities for Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP). Mentor and trainer for inspectors for good practices. Impressive understanding of Good Pharmacovigilance Practices.

Aiming to leverage my abilities in ensuring that medicines and specialized products used by children are safe, efficacious and of acceptable quality.

Robert

Robert

Robert currently lives in Kalama, Wa, and is a graduate of Weber State University, Ogden, UT. Robert started his career in the Air Force in 1987 and is a two-time graduate of the United States Air Force School of Aerospace Medicine. He graduated in 1988 with a certificate in Aerospace Medicine and in 1996 with a certificate in Aeromedical evacuation. He retired in 2022 as a lieutenant Colonel and the Chief of Staff for the Medical Readiness Training Command with three combat deployments and over 200 hundred hours of combat missions evacuating sick and injured service members.


Robert started as a coordinator in the summer of 1997 and, monitoring clinical trials in January 2002. He has specialized in mentoring and training as a Principal CRA, and GCP audits since 2006.  Robert has conducted multiple vendor and site audits. His last position was as a global lead for the Moderna Pediatric Vaccine, which was fast-tracked to approval.  Robert spends his free time with his family traveling and spending time outdoors.

Annie

Annie

After her Bsc. in Chemistry from the University of Paris XI, Annie Volet made her first steps in the food and pharmaceutical industries in the field of quality assurance and quality control. She then broaden her expertise with a MSc in Pharmacovigilance and Pharmacoepidemiology from the University of Bordeaux. In 2021, she worked in the conduct and the conceptualisation of the CIOMS working group on Good Governance Practice for Research Institutions and managed a training platform in research ethics evaluation.


Experienced in systematic review, she conducted a research related to vaccines risk communication publicated in 2022. Passionate about PV Management of spontaneous notifications and Monitoring of scientific and medical literature.

Don

Don

I have worked in the clinical research industry since the 1980s, beginning in infectious diseases as a clinical research associate. I gathered other medical specialty experience in the cardiovascular/renal fields, as well as metabolic medicine. Advancing to clinical project management, I was fortunate to assist in the approval process for two different medications, one in infectious diseases and one in the cardiovascular area. I moved into Phase IV clinical research and gathered experience in medical devices. Following a 14 year career at a large pharma company, I began consulting and worked for a large vaccine development company for five years.

Beginning in 2012, I was given the opportunity to begin clinical auditing and worked for several years in oncology auditing. I furthered my career by auditing women’s health research projects, dermatologic and other specialty disciplines as well as medium and large GLP projects. Most recently, I have focused my auditing on various oncologic sub-specialty areas as well as CRO audits and process development.

Referral Services

Jim Sanders

Jim Sanders

MPH

Jim is the president and owner of ClinOhio Research with over 20 years of clinical research experience. He has completed over 150 studies ranging from animal research to human research in phases 1-4. He earned his Bachelor of Science in Biology from the University of Southern Indiana and his Masters of Public Health from The Ohio State University. He started ClinOhio Research in 2017. 

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