About
Summary
The only time success comes before work is in the dictionary.
Positions
Drug Safety Operations Specialist Jan 2017 -
- Receive, triage, review and process Lifecycle Safety data from various sources on time, within quality standards. Perform data entry for tracking and Lifecycle Safety data bases, coding relevant medical terminology, writing descript narratives, generating queries pertinent to the case, performing quality control, assisting with reconciliation, driving case closure, coordinating translations and ensuring reports are sent to the customer within assigned deadlines. Pre-process material for endpoint committee or core laboratory adjudication. Preparation of material for submissionof secondary review.
- Assess Lifecycle Safety data report ability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups per legislation, within timelines and in a format compatible to requirement. Liaise with local departments.
- Contribute to individual deliverables in the field of Safety Publishing, Risk Management, Safety surveillance and Medical information or other service line sas appropriate.
- Process Lifecycle data according to applicable regulations, guidelines, Standart Operation Procedures (SOPs)and project requirements.
- Mentoring less experienced or new stuff members.
Drug Safety Associate Oct 2015 - Dec 2016
- Responsible for entry and the evaluation and assessment of case reports for seriousness, global listedness and causality of all serious and non-serious adverse events.
- Structured entry of serious and non-serious adverse events onto Client’s global PV safety database according to Client’s User Manual.
- Extraction of relevant information from routine source documents and/or information coming from the Client affiliates via the LAM or from E2B messages
- Preliminary evaluation and assessment of case reports for seriousness, global listedness and causality of all serious and non-serious adverse events
- Accurate and timely AE/SAE data entry taking into account the automated case prioritization by Client’s global PV database and timely processing of action items considering the system-generated due dates for completion.
- Creation of comprehensive case descriptions (narratives) in English language 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
- Processing of adverse events reports in the ARGUS Local Affiliate Module (LAM) tool according to Bayer’s Argus LAM User Manual.
- Review and process incoming adverse event information (especially at oncological field)
- Perform duplicate search of every adverse event reports to avoid duplication of case.
- Minimal data entry for English source document.
- Full data for non English source document.
- Requesting follow-up information from reporter (eg. Inconsistent information, clarification, incorrect source documents, incomplete information etc.).
- Review of local literature and processing of adverse events per literature report. - Responsible for entry and the evaluation and assessment of case reports for seriousness, global listedness and causality of all serious and non-serious adverse events
- Structured entry of serious and non-serious adverse events onto Client’s global PV safety database according to Client’s User Manual.
- Extraction of relevant information from routine source documents and/or information coming from the Client affiliates via the LAM or from E2B messages
- Preliminary evaluation and assessment of case reports for seriousness, global listedness and causality of all serious and non-serious adverse events
-Accurate and timely AE/SAE data entry taking into account the automated case prioritization by Client’s global PV database and timely processing of action items considering the system-generated due dates for completion.
- Creation of comprehensive case descriptions (narratives) in English language 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
- Processing of adverse events reports in the ARGUS Local Affiliate Module (LAM) tool according to Bayer’s Argus LAM User Manual.
- Review and process incoming adverse event information (especially at oncological field)
- Perform duplicate search of every adverse event reports to avoid duplication of case.
- Minimal data entry for English source document.
- Full data for non English source document.
- Requesting follow-up information from reporter (eg. Inconsistent information, clarification, incorrect source documents, incomplete information etc.).
- Review of local literature and processing of adverse events per literature report.
Researcher associate Sep 2011 - Jun 2015
János Szentágothai Research Center, University of Pecs
My tasks ranged from immunocytochemistry to Western blotting. As a member of the Neuroscience Lab Team, I was responsible for immunocytochemistry, doing Confocal Microscopy Ca++-imaging and Western blott. Our team worked on mammalian retina.
Internship Jun 2011 - Aug 2011
Coordinating of the harvest work and evaluating the quality of the plants.
Organizing the workflow at the workplace.
Experience in handling chemical agents.
Work with the Veterinarian.
Education
University of Pecs, Faculty of Nature Science 2013 - 2015
Field of study: Biologist
Degree: Master degree
Thesis: Retinal Astrocytes
University of Pecs, Faculty of Nature Science 2010 - 2013
Field of study: Biology
Degree: Bachelor degree
Thesis: Retinal examination with Ca++ imaging technic.
Skills
Immuncytochemistry, Confocal Microscopy, Neuroscience, Ca++ imaging, Western Blotting, Molecular Biology, Cell Culture, Science, Microscopy, Tw-photon microscop, Research, Teamwork, Healthcare, Pharmacoviligance, Clinical Trial, English, Microsift Office, Public Speaking, Negotiation, Editing, Teaching, Document Management, Consulting, Argus Safety, Life Sciences,
Professional interests
Neuro, neurobiology, molecular biology, genetics, evolution, cell, retina
Awards
Schoolarship of the hungarian republic 2014
Languages
English, Hungarian, French,
CV
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Contact details
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