Experience

Pharma D&S

• Italy
• Business Consulting and Services
• 100 - 200 Employee

• Project Manager

  • Apr 2019 - Present

  • Deputy QPPV • Internal and external training • PhV Database User (Safety Drugs) • Collection and processing of adverse events from different sources • Management, recording and processing of adverse events collected in the context of an interventional clinical trial • Access to Eudravigilance for monitoring data in the EV database • Electronic submission of ICSRs / SUSARs to EMA through EVWEB • Submission of data concerning medicinal products using XEVMPD for both authorized products and IMP • Monitoring of medical literature through the use of databases (e.g. Medline, Excerpta Medica or Embase), review of local journals and EMA's medical literature monitoring (MLM) • Screening of websites or digital media under the responsibility of the client • PSURs / DSURs planning, drafting and submission • Drafting and updating of SOPs / WIs • Signal detection and management: safety surveillance and analysis also by EVDAS • Implementation and updating of PSMF • Drafting and updating of SDEA with commercial partners • Drafting and submission of RMPs • Collection and processing of local ADRs; follow-up request; maintenance of paper and electronic archives; • transmission of security information to Corporate in accordance with the SOPs • RNF management in accordance with the new legislation • Periodic review of the AIFA website to update local legislation Show less



GB Pharma S.r.l.

• Italy
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Pharmacovigilance Manager

  • Mar 2016 - Apr 2019

  EU-QPPV Clinical Trial Safety Officer EU-QPPV Clinical Trial Safety Officer



TEOFARMA S.R.L.

• Italy
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Drug Safety Officer

  • Sep 2008 - Mar 2016