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
2022.01 - 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
2019.01 - 2022.01
- 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
2018.01 - 2019.01
- 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
2017.01 - 2018.01
- 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
2013.01 - 2016.01
- 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
2004.01 - 2006.01
Biologist Degree - undefined
University of Bucharest
2000.01 - 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
2022.01 - Current
Sr. Specialist PV Compliance
AbbVie
2019.01 - 2022.01
Specialist PV Compliance
Allergan (former Actavis)
2018.01 - 2019.01
Senior PhV Expert
Teva
2017.01 - 2018.01
PV Associate
Actavis
2013.01 - 2016.01
Master's Degree -
University of Bucharest
2004.01 - 2006.01
Biologist Degree - undefined
University of Bucharest
2000.01 - 2004.01