SJ Pharma Consulting (USA)

SJ Pharma Consulting provides expert safety consulting to the pharmaceutical industry, specializing in pharmacovigilance audit, signal detection, and training. With both in person and Online training, learn the ins and outs of drug safety compliance, ensuring your pharmacovigilance operations will comply with the latest US and EU laws, regulations and guidance’s. Steve Jolley, CEO of SJ Pharma, has more than two decades of experience in drug safety and pharmacovigilance. Throughout his years in the industry, he has worked with over 100 clients in the US, Europe, Japan, India and China. Steve is an Adjunct Professor at Rutgers University and teaches part of their Master's degree in Drug Safety and Pharmacovigilance. Steve is also a member of the Drug Information Association’s training faculty and an instructor for the DIA’s Clinical Safety and Pharmacovigilance Certificate Program. In 2010, Steve was elected as chairman of the DIA’s Clinical Safety and Pharmacovigilance steering committee for North America.

Steve provides drug safety and pharmacovigilance Online training on which he address US, EU and ICH regulatory requirements. Internal PV audits of pharmacovigilance systems have become a requirement for all Marketing Authorization Holders. Browse our available in-person pharmacovigilance training and drug safety training courses below.

Drug safety compliance audit ensures a company's pharmacovigilance operations comply with applicable laws around the world. This audit ensures they are following regulations and guidance, in addition to providing a comparison to best practices of similar organizations. At SJ Pharma, we have conducted more than 100 safety audits and assessments since our beginnings in 2001. The team at SJ Pharma has developed a 50-page audit checklist covering the areas of strategy, organizational structure, quality processes, SOPs, and systems and PV risk management. Within each section, multiple audit questions reference the applicable law, regulation, or guidance, as well as best practices currently used by other companies. This approach highlights any compliance gaps present in the organization, which is our priority for remediation.

The team at SJ Pharma has developed a 50-page audit checklist covering the areas of strategy, organizational structure, quality processes, SOPs, and systems and PV risk management. Within each section, multiple audit questions reference the applicable law, regulation, or guidance, as well as best practices currently used by other companies. This approach highlights any compliance gaps present in the organization, which is our priority for remediation.