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Online Resumes with "FDA EMEA MHRA"

Sr. Director/Director Clinical Quality Assurance and Compliance

Over 19 years of Regulatory / Clinical Quality Assurance & Compliance / Auditing experience. Maintain an excellent knowledge base of all applicable Guidelines, FDA Regulations as well as best practices. I have prior interaction with the FDA, and EMEA/MHRA authorities, leading to successful outcomes. I am considered to be a strategic leader and planner effective in a team environment and customer service focused, with exc...

Tags for this Online Resume: Clinical Quality Assurance, Compliance, Auditor, GCP, Quality Systems, Director

Compliance Advise & Assurance Advisor and Auditor - 11 Years of Experience - Near 19348

I was an auditor of activities within clinical drug development at AstraZeneca , having 11 years experience of a wide variety of audits such as for-cause, pharmacovigilance, clinical site and systems audits. My major accomplishments include FDA, EMEA and MHRA inspections, and I have led external audits in a range of countries and cultures, for example in USA, Canada, India, and many countries in EU and Latin America. I h...

Tags for this Online Resume: Quality Assurance, Auditor, Pharmacovigilance, Bilingual (Spanish-English), Inspection Readiness, Lead Data Manager, Supported Oncology trials

Clinical Research/Pharmacovigilance - 3 Years of Experience - Near 10001

Current MPH Student in Epidemiology at Columbia University, PhD in Biological Sciences, experienced in Clinical Research Development & Management, Pharmacovigilance and Health Information Technology.

Tags for this Online Resume: SAS, Clinical Research, ICH-GCP, FDA/EMEA/MHRA, Drug Safety, Study Design, New York