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CURRICULUM VITAE
Alexandr Mészáros, MD
Postfach • CH-4016, Basel, Switzerland
+41796690441 • +4917624552047 • mesanyika@yahoo.com
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

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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

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PROFESSIONAL MEMBERSHIPS: DIA • ACRP • PIPA • ISoP
OTHER: Languages: English (fluent), German (fluent), Russian (fluent), Czech (fluent),
Hungarian (fluent), Ukrainian (fluent), Slovakian (conversational), Polish (conversational)