CV_AM-May2015
- 1. Page 1 of 3 CURRICULUM VITAE Alexandr Mészáros, MD Postfach • CH-4016, Basel, Switzerland +41796690441 • +4917624552047 • [email protected] PROFESSIONAL RESPONSIBILITIES 01/12/2014 – current, for different customers, Switzerland, Consultant for Pharmacovigilance and Clinical Development of Medicinal Products and Medical Devices, Development and implementation of safety surveillance QMS, providing pharmacovigilance related quality and compliance oversight, training and continuous improvement opportunities to safety and other business partners through assessment of pharmacovigilance systems and operations, facilitation of appropriate standards, KPI and metrics, identification of quality and regulatory compliance issues and support of remediation and Health Authority and audit CAPA follow-up 01/04/2013-30/11/2014 Acino Pharma AG, Aesch, Switzerland, Drug Safety Physician in large sized pharmaceutical enterprise: establishment, optimization and maintenance of the pharmacovigilance system of the Acino Group: supervises any third party contractor dealing with PV activities, especially the ones who act as QPPV and assume any other delegated PV responsibility according to effective regulations. Ensures that safety and benefit-risk ratio of the products are continuously evaluated and that any modification of the ratio and corresponding correctives measures are appropriately documented and communicated to competent Authorities as well as internally. Provides safety input into study protocols and reports, and regulatory documents (including label texts e.g., package leaflets, SmPC). Administrates quality assurance system and ensure continuous optimisation of internal and external PV-processes according to the Quality Standards of the Acino Group. In July 2013 promoted to Senior Manager Pharmacovigilance, in December 2013 Graduated Plan Officer`s deputy according to German Drug Law 01/05/2012 - 01/12/2012 ALCON Management, Geneva, Switzerland Clinical Site Developer at manufacturer and marketer of eye care products for the surgical, pharmaceutical and vision care sectors, where established a solid network of multinational relationships that facilitated the clinical site selection and throughout Europe with management and development of therapeutic facilities, including hospitals, clinics and physicians’ offices. Trained investigators and set up testing procedures. 1/03/2007 – 30/04/2012 BASILEA Pharmaceutica International Ltd, Basel, Switzerland, Drug Safety Physician in medium sized pharmaceutical enterprise: setting up and maintenance of functional Pharmacovigilance System according to current effective regulations on adverse event reporting, pharmacovigilance and risk management, timely management of Medical Information, Safety reports, Literature reviewing, Product profile, providing medical assessment and interpretation of data. Quality assurance leading to excellent levels of pharmacovigilance and quality compliance with national, international and worldwide regulatory requirements/standards/guidelines, proved understanding to identify, analyse and evaluate GVP/GCP/GMP/QMS system, created and maintained innovative tools enhancing pharmacovigilance work practices. 09/2004 – 02/2007 PAREXEL International GmbH, Berlin, Germany Clinical Research Associate (Czech Republic & Germany) in global service provider
- 2. Page 2 of 3 organisation: complex clinical operational tasks sound. Design and implementation of project driven processes, facilitation of audits, effective mentoring of entry level staff, practical judgement in the interpretation and application of regulations and standards, successful inter-country leadership providing high quality input from European sites 05/2004 – 08/2004 PRA International GmbH, Mannheim, Germany Senior Clinical Research Associate in global service provider organisation: Successful inter-country leadership, in-time global data collection, analysis and presentation to sponsor 07/2001 – 05/2004 ICON Clinical Research, Langen, Germany Clinical Research Associate in global service provider organisation: Standardized operational support of multicultural projects in fast growing environment, complex clinical operational tasks 07/1999-06/2001 PHARMNET s.r.o., Prague, Czech Republic Position: Clinical Research Associate (Czech Republic, Slovak Republic, Hungary) in global service provider organisation: Standardized set-up of the clinical trials including investigator meetings, monitoring, close-out visits, administrated preparation and facilitation of audits Career Note: Medical Advisor, Handicap Technology Czech s.r.o., Prague, Czech Republic; Epidemiological Monitor, State Health Institute, Prague, Czech Republic; Clinical Pathology Monitor, Institute for Mother and Child’s Care, Prague, Czech Republic; Scientific Assistant in Genetics, Academy of Sciences, Prague, Czech Republic; Sales Representative of Medical Equipment, Prague, Czech Republic; and Primary Care Physician (family medicine), Trebisov, Ceska Lipa, Most, Czechoslovakia EDUCATION Post-Graduate Studies in Pharmacovigilance with Pharmacoepidemiology University of Hertfordshire, London, England / 2010 - Post-Graduate Training in Psychotherapy Charles University, Prague, Czech Republic / 1997-2001 Doctor of Medicine (Internal Medicine) Uzhgorod State University, Medical Faculty, Uzhgorod, Ukraine / 1982-1990 MAJOR TRAINING COURSES: 2013: Pharmacovigilance Forum, Vienna, AT 2011: 1st Information Day on Development Safety Update Report (DSUR) Guidelines ICH E2F 2009: GCP Refresher Training Programme (Ann McGee Consulting Ltd), Basel, CH 2009: MedDRA coding basics, web seminar, Basel, CH 2009: Introduction to MedDRA Data Analysis and SMQs for Physicians, Düsseldorf, Germany 2009: Handling Sponsor Inspections (QuAlitus), Basel, CH 2007-2008: Drug Safety Research Unit - 3 short courses, Southampton, UK 2007: Workshop “Pharmacovigilance Case Management”, Swissmedic, Bern, CH 2007: Real-Time Adverse Event Analysis using IVR, Basel, CH 2007: EDC (InForm™ ver. 4.5) Training, Basel, CH 2006: ICH-GCP guidelines refresher training, Berlin, Germany 2004: Electronic Trial Master File, Electronic Data Capture, Mannheim, Germany 2001-2004: Training on drug development (e.g. ICH-GCP, Fraud and Misconduct) Safety monitoring / Monitoring workshops, Territory planning), Langen, Germany 1999-2001: Monitoring according to ICH-GCP, Prague, Czech Republic
- 3. Page 3 of 3 PROFESSIONAL MEMBERSHIPS: DIA • ACRP • PIPA • ISoP OTHER: Languages: English (fluent), German (fluent), Russian (fluent), Czech (fluent), Hungarian (fluent), Ukrainian (fluent), Slovakian (conversational), Polish (conversational)