Giulia Pascucci

-Manage internal and external product technical complaints for liquid and solid products manufactures at Supply Center Berlin. - Prepare a summary report in English on each complaint and monitor any agreed improvement measures. - Review complaint samples and coordination of all activities of the production and quality control functions for complaints. - Conduct evaluations to detect trends / clusters of complaints and be able to take timely countermeasures (definition of CAPAs).

Pharmacovigilance safety dictionary (Argus) maintenance (products and studies set up), support in PVAs (pharmacovigilance agreements), Reporting Rules, AE case transmission to EMA/GDO, Notified Body reporting.

Entry of marketed product and studies reference information into the pharmacovigilance safety dictionary (Argus), survey on ICSR Reporting Requirements.

Professional training on the Pharmacist role, his obligations and responsibilities according to the Italian and European legislation, medication storage, delivery of prescriptions, galenic preparations.

Taking part in the activities of the Ethics Committee for Clinical Trials of Drugs and in the process of updating of the Therapeutic Formulary, support the Pharmacovigilance manager in the transmission of the reports of serious ADRs within the National Network of Pharmacovigilance AIFA.

Adverse Drug Reactions, Vaccine-vigilance, Phyto-vigilance, Pharmacovigilance of medical devices, Regulatory Affairs (PSUR, RMP), Pharmacoepidemiology, Clinical Trials

Topic of the Essay: “Potentially inappropriate medical prescriptions in geriatrics patients with psychiatric illnesses: comparison between the two different methods for their detection at psychogeriatric ward at the Bezirksklinikum of Regensburg (Germany)”