Summary
Overview
Work History
Education
Skills
Websites
Personal Information
Certification
Languages
Timeline
Generic
Mioara Dumitrașcu

Mioara Dumitrașcu

Assistant Professor
Bucharest,B

Summary

Experienced pharmacovigilance specialist with over 10 years in the pharmaceutical industry, skilled in overseeing compliance, managing Individual Case Safety Reports (ICSRs), data analysis and support audits.

Overview

13
13
years of professional experience
3
3
Certifications

Work History

Assistant Professor

University of Bucharest
Bucharest, Bucuresti
01.2022 - Current
  • Conducting botanical laboratory lessons and field activities
  • Analyzing and interpreting the research data and disseminate the findings via journals within the scientific community

Sr. Specialist PV Compliance

AbbVie
Bucharest, Bucuresti
01.2019 - 01.2022
  • Monitoring ICSR and aggregate reports compliance
  • Audits and inspections support
  • Late ICSRs investigations
  • CAPAs completion from audits, regulatory inspections, and investigation reports
  • Participate in cross-functional meetings to streamline the pharmacovigilance processes
  • Safety Data Exchange Agreements (SDEAs) review for the safety data exchange timelines
  • Communication with IT personnel for safety database updates

Specialist PV Compliance

Allergan (former Actavis)
Bucharest, Bucuresti
01.2018 - 01.2019
  • Monitoring ICSR and aggregate reports compliance
  • Analyse metrics for critical processes to ensure high quality and compliance with regulatory requirements and Company SOPs
  • Audits and inspections support
  • Late ICSRs investigations
  • CAPAs completion from audits, regulatory inspections, and investigation reports

Senior PhV Expert

Teva
Bucharest, Bucuresti
01.2017 - 01.2018
  • Data entry in ARISg safety database and expedited reporting of ICSRs to Heath Authorities and Business Partners
  • Quality review of ICSRs
  • MedDRA coding and Listedness assessment
  • Perform follow-up activities as applicable and document
  • Training and mentoring of the PV member's staff
  • Participated in periodic updates and SOP/WI responsibilities
  • Respond to Authority enquires on PV related matters with appropriate data, within the established timeframes

PV Associate

Actavis
01.2013 - 01.2016
  • Data entry of ICSRs in ARGUS safety database
  • MedDRA coding, QC control of ICSRs
  • Monitoring of EudraVigilance for incoming electronic ICSRs from different National Competent Authorities
  • Monitoring PhV safety mailboxes
  • Expediting reporting of ICSRs to Heath Authorities and Business Partners
  • Reconciliation with Business partners

Education

Master's Degree -

University of Bucharest
01.2004 - 2006.01

Biologist Degree - undefined

University of Bucharest
01.2000 - 2004.01

Skills

Key performance indicators

Publishing research

Interdisciplinary collaboration

Lesson planning

Mentoring students

Student research guidance

Task prioritization

Data analysis

Analytical skills

Time management

Documentation management

Key performance indicators

Personal Information

Driving License: B

Certification

Regulatory Affairs Training, 10/01/14, Bucharest, Romania

Languages

  • Romanian, native
  • English, C1
  • French, B2

Timeline

Assistant Professor

University of Bucharest
01.2022 - Current

Sr. Specialist PV Compliance

AbbVie
01.2019 - 01.2022

Specialist PV Compliance

Allergan (former Actavis)
01.2018 - 01.2019

Senior PhV Expert

Teva
01.2017 - 01.2018

PV Associate

Actavis
01.2013 - 01.2016

Master's Degree -

University of Bucharest
01.2004 - 2006.01

Biologist Degree - undefined

University of Bucharest
01.2000 - 2004.01
Mioara DumitrașcuAssistant Professor