Morteza Taherzadeh

Amgen

2013 to 2014
Global Safety Director
Amgen

2012 to 2014
Principal responsibilities
Amgen
Thousand Oaks, CA
2007 to 2014
Global Safety Director
Amgen

2007 to 2012
Principal responsibilities
Amgen
Cambridge
2005 to 2007
EU Safety Manager
PFIZER
Sandwich
1999 to 2005
Risk Management and Clinical Safety Scientist
Products Regulatory Agency (MHRA)
London, OH
1998 to 1999
Scientific Classifier

School of Hygiene and Tropical Medicine
London
2004
certificate
St Thomas
London
1998
Ph.D. in Clinical Pharmacology Department
Imperial College School of Medicine
London
1995
diploma in immunology
King's College, London University
1994
B.Sc. in Pharmacology
Shiraz University
1976 to 1980
Medical School in Medicine

With in-depth and outstanding knowledge and working experience in all aspects of<br/>Pharmacovigilance within the pharmaceutical and biotechnology industry as well as in a<br/>regulatory agency over 16 years. The main areas of expertise include the followings:<br/><br/> Periodic safety reports (e.g., PSUR, DSUR, PADER), Subject matter expert in Amgen<br/> Serious adverse events processing and review <br/> Signal detection through individual cases and aggregate data analysis<br/> Risk Management Plan document<br/> Drug safety evaluation in oncology and other therapeutic areas<br/> Preparing and overseeing safety assessment reports<br/> Informed Consent Form and Company Core Safety Information development <br/> Statistical methods and pharmacoepidemiology<br/> MedDRA, WHO drug dictionaries<br/> Computer systems and applications such as, ARISg, Argus, and Spotfire<br/> Literature monitoring <br/> EU, FDA and other major countries pharmacovigilance regulations<br/> Regulatory INSPECTION/INTERNAL AUDITS<br/> Leadership<br/> Regulatory filing<br/> Outsourcing of safety periodic reports to external service providers<br/> Management of external service providers<br/> Development of SOP and training materials<br/> Problem solving<br/> Safety analysis planning<br/> Presenting scientific topics in meetings<br/> Pharmacovigilance agreements with business partners<br/> Toxicology and pharmacokinetics