I provide expert safety consulting to the pharmaceutical industry, specializing in pharmacovigilance auditing and signal detection.
I have 30 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