Diego Palumbo

Pharmacovigilance Operations Specialist @Alfasigma

Bologna, IT

Management of the Pharmacovigilance activities in compliance with the National and EU regulations for differents kinds of medical products.• Daily Access to the Italian Pharmacovigilance Network (Rete Nazionale Farmacovigilanza)• Daily management of Complaints, Voice Messages and Medical Enquiries• Daily Access to the EVWEB - Eudravigilance• Daily check Medical Literature Monitoring - MLM• Case processing (MedDRA coding, triage, data entry, quality check, submission) for Drug, Medical Devices and Food Supplements.• Use of MedDra Dictionary• CIOMS Form I - editing and trasmission• Drafting and updating of PV/Service Agreements with Partners/Affiliates• Ensuring management of PV deviations and risk mitigation by defining appropriate CAPAs• Literature searches both for Medicinal Product and Active Substances and Medical Device• Preparing Electronic register for ADRs• Provide local data as required to support the preparation of aggregate reports (PSUR)• Submitting PV reports to local Health Authorities• Writing of SOP and WI.• Setting up/performing training program for company personnel (PV/non-PV) and partners/providers.• Use of PV-Database: PcvManager - Aris-G

EC English Language Centres Alumni

Intensive English Course (3 weeks), Brighton (Uk)

Università degli Studi di Napoli Federico II

Doctor of Pharmacy - PharmD, Class LS 14/S, Pharmacy

Università degli Studi di Napoli Federico II

License to practice, registration as a pharmacist

Università degli Studi di Napoli Federico II

Bachelor's Degree in Scientific information about drug and diagnostic products

Università degli Studi di Verona

Post-graduate II Level Master Course in Pharmacovigilance and Regulatory Affairs, Pharmacovigilance and Regulatory Affairs