Experience

CROMSOURCE - A ClinChoice Company

• Italy
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Pre-Market Pharmacovigilance Specialist Consultant - Chiesi Farmaceutici dedicated

  • Jan 2022 - Present

  - Review of SAE/eSAE received for Clinical trials; - Overall SAEs monitoring and tracking; - Support in the preparation of documentation for SUSAR/other safety reporting submissions; - Support in SAE reconciliation activities; - Performing PV activities for the set-up phase of clinical trials; - Support in the preparation of PV documents for submission to the Ethics Committees, investigators and Regulatory Authorities; - Support in the selection, verification and supervision of the CRO and other providers; -Performing PV activities for the closure phase of clinical trials. Show less



LABORATORI GUIDOTTI S.P.A.

• Deputy of the Local Drug Safety Unit Manager

  • May 2020 - Jan 2022

  -Responsible for the management of all PHV activities at local level on base of the Company's needs or in the absence of Local Drug Safety Unit Manager -Revision of PV Agreements; -Point of contact with Providers and Partners; -Training to new entry in PHV; -KPI managment -Responsible for the management of all PHV activities at local level on base of the Company's needs or in the absence of Local Drug Safety Unit Manager -Revision of PV Agreements; -Point of contact with Providers and Partners; -Training to new entry in PHV; -KPI managment



ISTITUTO LUSO FARMACO D'ITALIA SPA

• Italy
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Deputy of the Local Drug Safety Unit Manager

  • Feb 2020 - Jan 2022

  -Responsible for the management of all PHV activities at local level on base of the Company's needs or in the absence of Local Drug Safety Unit Manager -Revision of PV Agreements; -Point of contact with Providers and Partners; -Training to new entry in PHV; -KPI managment. -Responsible for the management of all PHV activities at local level on base of the Company's needs or in the absence of Local Drug Safety Unit Manager -Revision of PV Agreements; -Point of contact with Providers and Partners; -Training to new entry in PHV; -KPI managment.



MENARINI Group

• Pharmaceutical Manufacturing
• 700 & Above Employee

• Pharmacovigilance Medical Assessor for Italian Local Drug Safety Units

  • Jan 2020 - Jan 2022

  - Managment of spontaneous and literature cases; - Management of cases downloaded from Eudravigilance; - Review of the Aggregate Reports (PSUR, ADCO and RMP) and submission to the Competent Authorities; - International and local literature screening; - Signal detection activity; - Training to vendors and pharmaceutical representatives; - Revision of pharmacovigilance agreements (e.g. with Partners, vendors); - PSMF maintenance for the concerned Annexes under local unit responsibility; - Supporting for Key performance indicators (KPIs) management; - Supporting for managment of market researches; - Screening of Health Authority websites; - Reconcilation activities; - Collaboration with other functions for specific projects; -Documentation management and archiving. Show less



Roche

• Switzerland
• Biotechnology Research
• 700 & Above Employee

• Drug Safety Trainee

  • Apr 2019 - Dec 2019

  -Management of pharmacovigilance reports (spontaneous, from compassionate use and PTA, from market research, patient support programs and NIS) and data entry in the Company Safety Database (ARISg); - Follow-up requests; - Reconciliation activities;. - Review of the scientific literature and Company press release; - Review of market research questionnaires; - QC activities; - Collaboration with other functions for specific projects; - Supporting for PV training to internal functions; - Documentation management and archiving. Show less



Farmacia Cuomo

• Castellammare di Stabia (NA)

• Pre-degree Internship

  • Oct 2015 - Jan 2016



Farmacia Cuomo

• Castellammare Di Stabia (NA)

• Pre-degree Internship

  • Nov 2014 - Jan 2015