Experience

P95

• Belgium
• Research Services
• 1 - 100 Employee

• Satety Scientist

  • Jul 2023 - Present



Medpace

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Clinical Safety Manager

  • Jan 2023 - Jul 2023



P95

• Belgium
• Research Services
• 1 - 100 Employee

• Safety Scientist

  • Jun 2022 - Jan 2023



Alimentiv

• Canada
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Clinical Safety Specialist

  • Jul 2021 - May 2022



PRA Health Sciences

• United States
• Research Services
• 700 & Above Employee

• Senior Drug Safety Associate

  • Nov 2020 - Jun 2021

  Functioning as a drug safety team lead for clinical studies (phase I-III, therapeutic areas: oncology, vaccine and virology)Managing international teams of drug safety associates and safety assistants for full-service projectsBeing responsible for the quality of work from the drug safety teams’ side on project levelWorking closely with regulatory, medical and clinical departments in order to fulfill the pharmacovigilance requirements as per Good Clinical Practice (GCP) and regulatory requirementsHolding trainings for team membersPresenting on bid defense, kick off and investigators’ meetingsDrafting safety budget and drug safety relevant details of contractsSetting up and maintaining the projects’ safety related processes, documents and systems Reviewing and giving feedback for drafted protocols of clinical trialsAttending to regular sponsor and internal teleconferences as the key contact of the safety teamDeveloping and updating the safety management plan, including the safety reporting requirementsReporting and forecasting of monthly finance status to project managementQuality controlling of team activities (such as adverse event case processing, submitting of safety letters, tracking, and filing)Management and registration of EudraVigilance profiles as well as MHRA (Medicines and Healthcare products Regulatory Agency) related portals/gateways, acting as the responsible person on behalf of sponsorsSupporting the generation of development safety update reports (DSURs), and other applicable annual safety reports for the Latin American regionConducting literature search and review for DSURsResponsible for being interviewed and giving response to findings during external and internal safety auditsManaging drug safety responsibilities due to local representation Show less

• Drug Safety Associate

  • Mar 2017 - Nov 2020

  Serves as safety functional team lead and coordinates international teams of drug safety associates and safety assistants on project level, serves as the drug safety point of contact for study teams on project levelReports and forecasts project status (including monthly metrics) to project managementAdheres to financial and administrative processes, such as managing project budget and timelines, estimation of resource needs and projected hoursQuality control of data entry, reportability assessment and submissions to Regulatory AuthoritiesResponsible for the development of the safety section of the Safety and Medical Management Plan, including development of specific processes to assure consistency within the projectSupports analysis and quality control during the generation of Aggregated Safety Reports (e.g. Periodic Safety Update Reports)Submits expeditable safety reports to Regulatory Authorities, IRB/ECs, and investigational sites, including electronic submission to the EudraVigilance databaseGenerates data listings from the safety database and assumes responsibility for accuracy of the dataSupports interim data analysis for DMC reviewsQuality checks of individual case safety reports (ICSRs) from clinical trials and post-marketing projects Show less



Tata Consultancy Services

• India
• IT Services and IT Consulting
• 700 & Above Employee

• Drug Safety Associate

  • Feb 2016 - Dec 2016

  Structured entry of serious and non-serious adverse events onto Client’s global pharmacovigilance (PV) safety database Extraction of relevant information from routine source documents Preliminary evaluation and assessment of case reports for seriousness, global listedness and causality of all serious and non-serious adverse events Creation of comprehensive case descriptions (narratives) Extracting relevant PV information from routine source documents Checking of incoming PV information for consistency and completeness Verification of the accuracy of MedDRA and WHO-DD coding of reported adverse events, concomitant drugs Show less



University of Szeged

• Hungary

• Research Intern

  • 2013 - 2015

  At Department of Genetics, I characterized a gene, which was probably involved in spermatogenesis. I took part in the whole process from designing of primers, through different types of polymerase chain reactions, to molecular cloning. At Department of Genetics, I characterized a gene, which was probably involved in spermatogenesis. I took part in the whole process from designing of primers, through different types of polymerase chain reactions, to molecular cloning.



Hospital of Kalocsa

• Hungary

• Summer Internship

  • Jun 2012 - Aug 2012

  Internship at the Department of Pathology, where I improved my skills in the fields of histology and cytology. Internship at the Department of Pathology, where I improved my skills in the fields of histology and cytology.