Csaba Gellert Geng

Csaba gellert geng

bookmark on deepenrich
location of Csaba Gellert GengFrankfurt Rhine-Main Metropolitan Area
Followers of Csaba Gellert Geng368 followers
  • Timeline

  • About me

    Global Safety Officer at Sanofi

  • Education

    • University of medicine and pharmacy of targu mures

      2006 - 2013
      Doctor of medicine (m.d.)
  • Experience

    • Mlsz - magyar labdarúgó szövetség (hungarian football federation)

      Jun 2014 - Sept 2014
      Pitch-side emergency doctor

      Provide match day emergency cover for players and officials:- 2016 UEFA Euro 2016 Championship Qualifying- 2015 FIFA Women’s World Cup Qualification- 2014 UEFA European Under-19 Championship

    • Tata consultancy services

      Jan 2015 - Nov 2017

      - Leading a team in Drug Safety offering Pharmacovigilance services to Clients delivering a high quality data in stipulated timelines.- Interactions and telecons - Coordinate and communicate effectively with primary contacts at Client teams to ensure satisfactory progress of project work and timely resolution of issues.- Ensure compliance to SOPs and relevant documentation.- Involve in direct reportees development in identifying training need.- Overall in-charge of day-to-day activities for team in Pharmacovigilance/Drug Safety.- Oversight of direct reportees activities, leave management and conduct regular team meetings.- Escalation of identified unresolved issues to project leader and manager on time and ensure issue resolution in a timely manner.- Overview of all medicinal product safety profiles.- Responds to queries from authorities and or license partners. Show less Evaluation of Serious Adverse Event (SAE) cases (all serious, legal, spontaneous, observational studies, pregnancies) in accordance with regulatory requirements for AE reporting. Execution of a high-quality, accurate and timely SAE case evaluation and medical review process within cardiovascular and primary care products. Determination of the completeness of single case reports as to medical content, clarification of inconsistent information, and requisition of required additional information from the reporter. Confirmation of the accuracy of medical coding of all SAE and drug terms (MedDRA and WHO-DD). Show less -Translation of Italian source documents in English for LAM entry.-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. Perform duplicate search of every adverse event reports to avoid duplication of case. Minimal data entry for English source document. Full data entry 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 as per literature report. Show less

      • Pharmacovigilance - Team Lead

        Apr 2016 - Nov 2017
      • Drug Safety Physician

        Aug 2014 - Mar 2016
      • PV Officer (LAM)

        Jan 2015 - Jul 2015
    • Bayer

      Dec 2017 - Feb 2023
      • Expert Case Evaluator

        Jan 2022 - Feb 2023
      • Senior Case Evaluator

        Dec 2017 - Jan 2022
    • Sanofi

      Mar 2023 - now
      Global safety officer
  • Licenses & Certifications