
Carlos Bernaus
Bachelor of Science in Pharmacy, Master in Pharmacoepidemiology and Pharmacovigilance (thesis on comparative analysis in... | Cambridge, Massachusetts, United States
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Carlos Bernaus’s Location Cambridge, Massachusetts, United States
Carlos Bernaus’s Expertise Bachelor of Science in Pharmacy, Master in Pharmacoepidemiology and Pharmacovigilance (thesis on comparative analysis in risk management plans). Project Management Certification, McGill University, Over 10 years of experience in monitoring pharmacological use of drugs and more than 7 years in Quality Assurance / Regulatory Affairs. Extensive experience auditing: GMP, GDP, GCP, GLP, GVP, ISO 9000. Experience in reviewing and approving clinical studies in Trial Master Source (TMS). Submission of periodic and special pregnancy reports to Health Canada and to the Food and Drug Administration (FDA). Coordination of EPO antibody testing EPREX program to physicians. Preparation of comparative statistical analysis of seriousness and frequency of events between drugs from one pharmaceutical company and drugs from competitors, impact of drug holidays in frequency of adverse events, etc. Designed and implemented a novel follow-up (outcome and causality) approach utilizing advance Microsoft Excel functions. This project was one of ten selected among those that participated in the first J&J innovation fair with savings of 1,000,000 per year. All follow-up attempts arising from 8,000 cases per month (90,000 annually) were completed within 20 calendar days with 2.5 headcounts. Participation in internal global working groups on numerous projects with extensive project management experience. Strong computer skills: Excel, Word, Power Point, Access. SCEPTRE, in-house developed event management system, LCRx, OST, LAT. AERS, Argus-LAM, ARISg, PV Central, PV Reports. Veeva Vault, TrackWise. Experience with SPSS (Statistical Package for the Social Sciences), STATA , SQL (Structured Query Language), Power BI Desktop (Business Inteligence), Tableau. ISPOR training: budget impact analysis (BIA); pharmacoeconomics; modeling health care costs. Authored the first book on Adulteration and Falsification of Medicines. Fluent in English and Spanish, intermediate knowledge of French.
Carlos Bernaus’s Current Industry An American European
Carlos
Bernaus’s Prior Industry
Universidad De Buenos Aires
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Praxair
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Independent Pharmaceutical Consultant
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Forbenton Co Laboratories
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Genpharm
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Mylan
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The Janssen Pharmaceutical Companies Of Johnson And Johnson
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An European
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An American
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An American European
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Work Experience

An American European
Pharmacovigilance Quality and Compliance
Wed Aug 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
An American
Associate Manager, Drug Safety
Thu Sep 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Dec 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time)
An European
Project Quality Manager
Mon Feb 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Aug 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time)
The Janssen Pharmaceutical Companies Of Johnson And Johnson
Drug Safety & Surveillance Supervisor
Tue Sep 01 2009 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Sep 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time)
Mylan
Drug Safety Officer
Tue Jan 01 2008 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Jan 01 2009 00:00:00 GMT+0000 (Coordinated Universal Time)
Genpharm
Drug Safety Associate
Sun Jan 01 2006 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Jan 01 2008 00:00:00 GMT+0000 (Coordinated Universal Time)
Forbenton Co Laboratories
Associate Technical Director
Mon Sep 01 2003 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Jul 01 2005 00:00:00 GMT+0000 (Coordinated Universal Time)
Independent Pharmaceutical Consultant
Pharmaceutical Consultant
Wed Jan 01 2003 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Jan 01 2005 00:00:00 GMT+0000 (Coordinated Universal Time)
Praxair
Technical Director
Sun Apr 01 2001 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Sep 01 2003 00:00:00 GMT+0000 (Coordinated Universal Time)
Universidad De Buenos Aires
Instructor in Quality Control
Fri Sep 01 1995 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Mar 01 2002 00:00:00 GMT+0000 (Coordinated Universal Time)