Dr Giovanni Furlan
Proposed Good PV outsourcing standards
Helsinn Birex Pharmaceuticals Ireland
Giovanni Furlan has 15 years of experience in the drug safety arena and a degree in Chemistry and Pharmaceutical Technology, a qualified pharmacist. Started with processing cases in a major pharma Company. Since then setup, developed and managed drug safety units, integrated the safety operations of two pharmacovigilance departments. Qualified Person Responsible for Pharmacovigilance (EU QPPV) and Local Responsible Person for Pharmacovigilance. Led a team of medics in charge of analyzing the Company’s products evolving safety profiles. Worked at local, European and global level in medium and big pharma and in a CRO. Holds a unique blend of operational and scientific skills. Expert in all aspects of the pharmacovigilance system, preparation of aggregate reports, signal detection and evaluation, interaction with regulatory authorities. Successfully undergone audits and inspections Author/co-author of articles on signal detection, risk management plans, periodic safety update reports, development safety update reports, causality assessment. Proposer of the product safety master file and of unifying clinical and drug safety databases (articles published in Drug Safety and Current Drug Safety) Delivered presentations in a number of congresses.