Profilo professionale
Panoramica
Esperienza lavorativa
Istruzione
Competenze
Languages
Cronologia
Generic

Michele De Pace

Roma,Italy

Profilo professionale

Job Title: Pharmacovigilance Responsible and PhV Safety Database Responsible.

Pharmacovigilance specialist with more than 8 years of experience in the sector. Preparation gained within the postmarketing pharmacovigilance. In-depth knowledge of GVP and current legislation in pharmacovigilance and regulatory issue

Panoramica

2016
2016
years of professional experience

Esperienza lavorativa

PhV Safety Database Responsible

Di Renzo Regulatory Affairs
Roma, RM
01.2024 - ad oggi
  • Interacts with the Safety Database Provider to solve any potential issues with the Safety Database
  • Collaborates with the PV Unit Responsible/Deputy, PV QA Unit, IT Unit and Management on any aspects concerning the Safety Database
  • Collaborates with the PV Unit and PV QA Unit for the update of SOPs/Wis concerning the Safety Database

Pharmacovigilance Responsible

Di Renzo Regulatory Affairs
Roma, RM
07.2022 - ad oggi
  • Acting as main contact point for the Italian Competent Authority for safety issues and requests
  • Acting as main contact point in Italy for the EU-QPPV
  • Communicating to the EU-QPPV any local requirement and any modification of the national PV legislation
  • Transmitting to the EU-QPPV any safety request or enquiry originating from the Italian CA (AIFA)
  • Collaborating with dedicated personnel of PhV Unit to ensure that appropriate local procedures are in place for the performance of local PV activities
  • Collaborating with dedicated personnel of PhV Unit to ensure an appropriate collection, documentation, translation (into English), follow up, archiving and timely transmission to EU QPPV/PV Headquarter of case reports
  • Collaborating with dedicated personnel of PhV Unit to ensure that a periodic local literature search process is in place for all MPs with at least one license in Italy
  • Collaborating with dedicated personnel of PhV Unit to ensure the maintenance of a local tracking system for case reports
  • Collaborating with dedicated personnel of PhV Unit to ensure a case reports reconciliation on a periodic basis, as required by EU-QPPV/PV Headquarter
  • Collaborating with the EU-QPPV in the preparation of responses to safety requests or enquiries originating from the Italian CA (AIFA)
  • Submission of responses to the Italian CA (AIFA) enquiries
  • Performing regular training sessions on PV according to local procedures
  • Performing training sessions on PV to the Italian company’s employees and sales representatives, when applicable
  • Collaborating with dedicated personnel of PhV Unit to monitor CAPAs implementation
  • Being involved, in collaboration with the EU-QPPV, in the inspections performed at local level by the Italian CA (AIFA)
  • Collaborating with dedicated personnel of PhV Unit in the preparation and editing, in collaboration with the EU-QPPV, the responses to findings raised during the inspections performed by the Italian CA (AIFA) at local level
  • Collaborating, when required, with CCs medical staff and EU-QPPV/PV Headquarters to the implementation at local level of RMMs contained in a RMP
  • Collaborate with the EU-QPPV/PV Headquarter in the management of sub-contractors used for PV
  • Being informed by the MAH of any local PASS

Quarterly Literature Quality Check

Di Renzo Regulatory Affairs
Roma, RM
01.2020 - ad oggi
  • Quarterly Quality Check of Literature search

Direct Cases Data Entry

Di Renzo Regulatory Affairs
Roma, RM
01.2022 - ad oggi
  • Receiving, filing and Data entry of ADR case reports into the Client Companies (CCs) Safety Database received either directly (e.g. by healthcare professionals, sales representatives, CC’s personnel) or by CC’s partners
  • Tracking of ICSRs received directly of by CC’s partners into specific registers
  • Submission to Eudravigilance and quality check

MAIN BACKUP FUNCTIONS

Di Renzo Regulatory Affairs
Roma, RM
  • ICSRs Submission to CC's Partners
  • ICSR Screening
  • Data Entry
  • Quality Control
  • Regulatory Intelligence

SECONDARY EDUCATION TEACHING PROFESSIONAL

LICEO SCIENTIFICO STATALE PRIMO LEVI
Roma, RM
09.2010 - 06.2015

Istruzione

BACHELOR DEGREE - ENVIRONMENTAL SCIENCE

Università di Roma “La Sapienza"
Roma

Diploma - Sciantifico

Liceo Scientifico statale "Primo Levi"
Roma

Competenze

  • Knowledge of basic pharmacovigilance and the organization of the pharmacovigilance system in Italy and European Union
  • Knowledge of ADRs management process within the Pharmacovigilance Unit (FVSOP-002; FVSOP-005)
  • Knowledge of the backup process for PV personnel (FVSOP-012)
  • Knowledge of the archiving procedure within the PV Unit (FVSOP-011)
  • Knowledge on how to handle personal data received by the PV Unit (FVSOP-014)
  • Scientific Degree
  • Good knowledge of Microsoft Office applications and general knowledge of PC
  • Good English communication skills
  • Good knowledge of EU Regulatory legislation
  • Knowledge of all the SOPs of the Di Renzo Pharmacovigilance System and of its Quality System impacting on Clients Companies for which Di Renzo acts as Italian Local Contact Point for Pharmacovigilance
  • General knowledge of EVWEB interface and download function
  • Knowledge of EudraVigilance Screening Process and “CTT” software (FVWI-012)
  • Knowledge of medical assessment principles and their management within the Di Renzo Pharmacovigilance Unit (FVWI-008)
  • Deep knowledge of literature management procedure within Di Renzo Pharmacovigilance Unit (FVSOP-007)
  • Knowledge of process on monitoring local literature (FVWI-017)
  • Good knowledge of the functions of Safety Drugs database related to the Data Entry activity (FVWI-007)
  • Knowledge of the processes for the management of direct cases
  • Good knowledge of the functions of Safety Drugs database related to the Data Entry activity and submission to Eudravigilance (FVWI-019)
  • Knowledge of the process for the submission of ICSRs to Partners (FVWI-010)
  • Knowledge of the use of the Reporting Register (FVWI-021)
  • Good knowledge of the functions of Safety Drugs database related to the Quality Control activity (FVWI-009)
  • Previous experience in ICSRs Data Entry

Languages

Italiano
Madrelingua
Inglese
Intermedio avanzato
B2
Spagnolo
Intermedio
B1

Cronologia

PhV Safety Database Responsible

Di Renzo Regulatory Affairs
01.2024 - ad oggi

Pharmacovigilance Responsible

Di Renzo Regulatory Affairs
07.2022 - ad oggi

Direct Cases Data Entry

Di Renzo Regulatory Affairs
01.2022 - ad oggi

Quarterly Literature Quality Check

Di Renzo Regulatory Affairs
01.2020 - ad oggi

SECONDARY EDUCATION TEACHING PROFESSIONAL

LICEO SCIENTIFICO STATALE PRIMO LEVI
09.2010 - 06.2015

MAIN BACKUP FUNCTIONS

Di Renzo Regulatory Affairs

BACHELOR DEGREE - ENVIRONMENTAL SCIENCE

Università di Roma “La Sapienza"

Diploma - Sciantifico

Liceo Scientifico statale "Primo Levi"

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