
Timeline
About me
Global Safety Officer at Sanofi
Education

University of medicine and pharmacy of targu mures
2006 - 2013Doctor of medicine (m.d.)
Experience

Mlsz - magyar labdarúgó szövetség (hungarian football federation)
Jun 2014 - Sept 2014Pitch-side emergency doctorProvide 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 2017Drug Safety Physician
Aug 2014 - Mar 2016PV Officer (LAM)
Jan 2015 - Jul 2015

Bayer
Dec 2017 - Feb 2023Expert Case Evaluator
Jan 2022 - Feb 2023Senior Case Evaluator
Dec 2017 - Jan 2022

Sanofi
Mar 2023 - nowGlobal safety officer
Licenses & Certifications
- View certificate

Basics of signal detection and pharmacoepidemiology
Dia groupJan 2021 - View certificate

Drug safety regulatory requirements
Dia groupJan 2021 - View certificate

Pre-marketing clinical trial safety
Dia groupJan 2021 - View certificate

Introduction to drug safety
Dia groupJan 2021 - View certificate

Post-marketing safety management
Dia groupJan 2021
Languages
- enEnglish
- huHungarian
- roRomanian
- itItalian
Recommendations

Binit mondal
Site Reliability Engineer @ Simplify360 | Bash |AWS | Python | CI/CD | Grafana | Prometheus | Git |...Bengaluru, Karnataka, India
Dinesh bohra
Equity Commodity CurrencyMumbai, Maharashtra, India
Denise sousa
Fisioterapeuta | Hospital das Forças ArmadasLisboa, Lisbon, Portugal
Matthew o'dea
Software Product Manager | Web & Mobile Apps | Specialized in 0 to 1 Launches, Full-Stack Developmen...Denver, Colorado, United States
Trishul raj u shetty
Project Analyst @Juego Studios | Game Production | Agile & Scrum Methodology | Team Management | Del...Udupi, Karnataka, India
Samiullah khan
Multimedia Specialist with 13+ years' experience in broadcast media, education, politics, & events. ...Hyderabad, Telangana, India
Frank bomberg andersen
Ejer hos QESH Consult ApSRødekro, Region of Southern Denmark, Denmark
Maunik panchal
Manager Procurement ( India & Thailand )Vadodara, Gujarat, India
Axel jonuschies
Ad Tech and Digital Marketing Expert | Global Investment Strategy Architect | Managing Director, AdT...Düsseldorf, North Rhine-Westphalia, Germany
Sakshi chanana
Student Placement Coordinator and a MBA Student at Maharishi Markandeshwar University, MullanaIndia
Renuka dv
Technical adviser/Consultant on Airborne EOEW SystemsBengaluru, Karnataka, India
E rajkumar desetti
Oracle Technical Analyst at KPMG Global Services (KGS)Andhra Pradesh, India
Jérémy despaux
Plants Manager Deputy chez ImerysGreater Bordeaux Metropolitan Area
Sha hong
Working on empowering business through digital marketingParis, Île-de-France, France
Mohammed shaco
Junior Backend DeveloperTripoli, Tripoli, Libya
Pooja m
Data Analyst at EY India | Ex - AccentureBengaluru, Karnataka, India
Mohamed elkazaz
Software Engineer @BMB | ITI GraduateCairo, Egypt
Leah guzzo
Data Business AnalystQuad Cities Metropolitan Area
Emily harshman
IT Infrastructure Portfolio Manager at MativAtlanta, Georgia, United States
Johan khalil mas'od
Senior Cost Engineer at PETRONASWP. Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia
...