About me
Global Pharmacovigilance ‘PV’ Consultant with twenty-eight years of solid clinical research experience and post-marketing in pharmaceuticals. Excellence in providing safety strategy to product development teams, ensuring timely and high-quality execution of safety documents such as safety management (SMP) and risk management plans (RMP). Safety assessment of global Suspected Unexpected Serious Adverse Reaction reports (SUSARs) and Serious Adverse Events (SAEs). Management of Pharmacovigilance Service Providers. Strong medical background, author of safety sections including Protocols, Informed Consent Forms (ICFs), SMP, RMP, RSI, Development Safety Update Report (DSUR), SAE/pregnancy forms.
