ioana frent
@ioanafrent
Senior Drug Safety & Pharmacovigilance leader ensuring compliant global safety oversight.
RomaniaWhat I'm looking for
I’m a Senior Drug Safety Manager / EU QPPV (and Deputy EU QPPV) and UK QPPV, providing end-to-end pharmacovigilance oversight across global safety processes. In my current role at ICON PLC, I act as interim Chief Medical Officer (Oct 2021–Oct 2022) and lead project delivery for a global PV department, including signal detection, Health Hazard Evaluation writing, and hosting Safety Committee Meetings to support informed safety decision-making.
I manage critical PV deliverables such as ICSRs, RMPs, aggregate safety reports, and PSMF maintenance, while developing SOPs and delivering PV training. Previously at Sun Pharmaceutical Industries Ltd., I served as Deputy EU QPPV/Pharmacovigilance Manager—maintaining regulatory compliance, driving CAPA through audits and inspections, coordinating medical review and medical writing (including EU RMP coordination), and ensuring reporting accuracy; earlier experience included Deputy EU QPPV/Case Processing Supervision and Medical Advisor pharmacovigilance work. With my medical background (Internal Medicine Specialist) and PhD in Pharmacovigilance, I bring strong clinical judgment to medical review, MedDRA coding accuracy, causality assessment, and quality-first governance.
Experience
Work history, roles, and key accomplishments
Serves as EU QPPV/UK QPPV and provides safety physician activities across signal detection, safety committee support, health hazard evaluations, and medical review of ICSRs. Leads safety deliverables including ICSRs, RMPs, aggregate safety reports, PSMF maintenance, SOP development, PV training, and PV audits/gap analysis, and reviews study protocols.
Acts as backup for EU QPPV and manages updates to the Pharmacovigilance System Master File (PSMF) while maintaining regulatory compliance of cases. Coordinates medical review and medical writing teams, supports PV audits/inspections, implements CAPA, conducts PV training, and coordinates EU RMP activities.
Deputy EU QPPV Case Supervisor
Ranbaxy Laboratories Limited
Dec 2014 - Aug 2015 (8 months)
Coordinates the case processing team to ensure pharmacovigilance reporting compliance and manages case triage. Ensures timely processing workflows through team coordination to meet reporting requirements.
Medical Advisor, Pharmacovigilance
Ranbaxy Laboratories Limited
Apr 2007 - Dec 2014 (7 years 8 months)
Performs medical review of adverse drug reaction cases in the company database, including MedDRA coding accuracy checks and assessment of medical significance, seriousness, expectedness, and causality. Conducts follow-up activities to support accurate and compliant case management.
Education
Degrees, certifications, and relevant coursework
University of Medicine and Pharmacy Iuliu Hațieganu
Internal Medicine Specialist, Internal Medicine
2018 -
Internal Medicine Specialist (ongoing/current) at the Faculty of Medicine, with the title obtained in April 2018.
University of Medicine and Pharmacy Iuliu Hațieganu
Master's degree in Pharmacovigilance, Pharmacovigilance
2013 - 2014
Master degree in Pharmacovigilance at the Faculty of Pharmacy (2013 to 2014), with dissertation on intensive inpatient monitoring to detect side effects.
DIA (European Medicine Agency)
Training course, EudraVigilance / Signal Management
2021 -
Training on EudraVigilance Data Analysis System (EVDAS) for signal management (8–9 Jul 2021).
11th Romanian Pharmacovigilance Workshop
Workshop, Pharmacovigilance
2024 -
Participation in the 11th Romanian Pharmacovigilance Workshop (2–4 Oct 2024).
University of Medicine and Pharmacy Iuliu Hațieganu
PhD in Pharmacovigilance, Pharmacovigilance
2018 - 2024
PhD studies in Pharmacovigilance at the Faculty of Pharmacy, completed over 2018 to 2024 (end date 20 Sep 2024).
University of Medicine and Pharmacy Iuliu Hațieganu
Doctor of Medicine (MD), Medicine
1998 - 2004
Medical Doctor (MD) at the Faculty of Medicine (1998 to 2004).
Availability
Location
RomaniaAuthorized to work in
Job categories
Skills
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