Irina Ghiorghiu

Manage the Safety Data Exchange Agreements as well as the Pharmacovigilance Agreements for contractual relationships with business partners. Key contact person for internal and external stakeholders with all matters related to SDEAs/PVAs. Coordinated the preparation and conclusion of SDEAs together with relevant internal and external parties. Ensured compliance with PV regulations, guidelines and industry practice and actively support audits and inspections.

Set-up and maintenance of the local pharmacovigilance system Monitoring of national pharmacovigilance legislation Communication with French Competent Authorities Processing of local safety information Weekly monitoring of local literature review and monthly quality control checks

▪ Part of the global pharmacovigilance team, ▪ Full case processing, causality assessment, Meddra coding verification ▪ Good knowledge of pharmacovigilance database Safety Easy, including generation of CIOMS, line listings and summary tabulations ▪ Update of the PSMF; good knowledge of the pharmacovigilance quality system ( SOPs and working instructions) ▪ Signal detection process ▪ Reconciliation between clinical and pharmacovigilance databases ▪ Medical and scientific literature monitoring ▪ Elaboration of periodic safety reports (DSURs, PSURs in PBRER format) ▪ PV Monthly reports

▪ Suppletory responsable pharmacist in charge of teams up to 15 persons ▪ Frequents verifications of patient’s online pharmaceutical file for possible drug-drug interactions or redundant treatments ▪ Collected information on adverse drug reactions and report them further to concerned parties ▪ Organized weekly pharmacy staff meetings to discuss observance and improvement of pharmacovigilance SOPs

▪ Reviewed and filled prescriptions, entered orders in computer ▪ Supervised staff and conducted purchasing procedures, assisted in inventory control ▪ Trained new technicians in pharmacy computer operating ▪ Assisted in provision of pharmacy services, including dispensing medication, advising patients on usage of prescription and non-prescription drugs, monitoring patient profiles for drug interactions and treatment compliance ▪ Elaborated monthly reports to the National Health System regarding received prescriptions, and reported adverse events ▪ Collaborated with drug manufactures for post-marketing safety studies