Profile: 27 years of experience in the field of Pharmacovigilance, with a demonstrated history of working in the pharmaceuticals industry. Solid knowledge of Latin America and International (US / Europe) regulations, GCPs, GVPs and agencies organizational structures and processes with active participation in entities such as INTERFARMA, SINDUSFARMA, DIA, ISOP. Skill and experience in Quality Assurance with a focus in global pharmacovigilance audits and inspections and compliance across human health in pharmaceuticals, biologicals, devices and consumer care products (both pre- and post-marketing), including marketing partner and vendor activities. This background and experience provide me the ability to bring insights into how we can assess and control pharmacovigilance-related risk in marketing, market research, sales, clinical, regulatory, contract management and (of course) pharmacovigilance itself. Expertise in pharmacovigilance databases (Oracle AERS, Argus, Aris-G), MedDra, ICSR narrative writing, case submission to health agencies. Skilled in developing risk management plans (RMPs), Aggregated Reports (PSUR, PBRER), risk minimization activities, governance of patient support programs and market research initiatives, interaction with customer service, reportability rules and regulatory intelligence. International experience at Shands Hospital, University of Florida-USA. Languages Fluent written and spoken, English, Spanish and Portuguese. Working as a freelance PV auditor for a year, can audit subsidiaries from any country, more used to audit in Latin American countries (from Mexico to Uruguay) including the big countries like Brazil, Argentina, Colombia, Mexico, Chile) and expert in the legislation of these countries, but can audit any country. Based in Brazil.