I provide expert safety consulting to the pharmaceutical industry, specializing in pharmacovigilance auditing and signal detection.
I have 28 years’ experience in drug safety & pharmacovigilance and have worked with clients in the US, Europe, Japan, India and China. I have led over 100 drug safety and pharmacovigilance audits and risk assessments of companies, business partners, and contract research/safety organizations, typically followed by remediation efforts. I am member of DIA’s training faculty and instructor for DIA’s Clinical Safety and Pharmacovigilance Certificate Program. In 2010 I was elected chairman of the DIA’s Clinical Safety and Pharmacovigilance steering committee for North America.
I hold degrees in mathematics Read more
I provide expert safety consulting to the pharmaceutical industry, specializing in pharmacovigilance auditing and signal detection.
I have 28 years’ experience in drug safety & pharmacovigilance and have worked with clients in the US, Europe, Japan, India and China. I have led over 100 drug safety and pharmacovigilance audits and risk assessments of companies, business partners, and contract research/safety organizations, typically followed by remediation efforts. I am member of DIA’s training faculty and instructor for DIA’s Clinical Safety and Pharmacovigilance Certificate Program. In 2010 I was elected chairman of the DIA’s Clinical Safety and Pharmacovigilance steering committee for North America.
I hold degrees in mathematics and computer science from Cambridge University, England. I am an Adjunct Professor at Rutgers University and teach part of their Master's degree in Drug Safety and Pharmacovigilance.
Specialties: Drug safety and pharmacovigilance, training, auditing, compliance, signaling, data mining
