New Jersey 732.770.4100

 Drug Safety / Pharmacovigilance Associate

A Drug Safety / Pharmacovigilance Associate (DSA / PVA), known also in the industry as a Pharmacovigilance Officer, is a health science professional responsible for the monitoring, data collection and analysis, and reporting of drug safety information for compliance with drug safety regulations in the U.S. and international markets.

DSA / PVA also monitors and assesses drug safety requirements for drugs in the development pipeline as well as for those drugs approved that may require additional marketing or clinical action by the drug manufacturer. See program highlights for more information.

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Program Highlights

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Admission Requirements   Recommended: minimum a Bachelor degree in Public Health/Medicine, Pharmaceutical Chemistry, Pharmacy, Medical Technology, Pharmacy,Nursing, Pharmacology,Toxicology, Industrial Pharmacy, Healthcare professionals (RN, PA, MD, PT.PRh, PharmD or Medical Technologist)
Curriculum Overview Our program is approachable which provides in-depth knowledge and practical exposure to roles and responsibilities performed by Drug Safety / Pharmacovigilance Associate. It gives insight into base topics including but not limited to: Introduction to Clinical Research, Drug Development Process, ICH Guidelines for Good Clinical Practice, Drug Safety Regulations and Guidelines, Clinical Trial Protocol, SOP Development, Drug Safety Databases and Software, and Understanding of 21 CFR Part 11 and HIPAA.
Our program focuses on core topics of Drug Safety in reference to roles and responsibilities performed by Drug Safety / Pharmacovigilance Associate. Core topics includes Role of DSA (Trials), Clinical Trial Safety Surveillance, Phase IV Trials and Pharmacovigilance, Introduction To Adverse Events, SAE Reconciliation, Characteristics of a Case, Sources of Individual Case Reports, Basics of Coding in Drug Safety, Case Narratives, Case Follow-up Approaches and Handling of Cases and Drug Safety Data Extraction and Pre-processing. Thus, Program offered at Qtech will provide students an edge to get into opportunities in the Drug Safety field.
Teaching Methodology Available as self paced training (PIP, pure internet program)
Career Opportunity Pathways Drug Safety / Pharmacovigilance Associate, Drug Safety Scientist Case Processor, Triage Specialist, Narrative Writer, Medical Record Extractor, Senior Drug Safety / Pharmacovigilance Associate, Medical Reviewer
Duration 45 days
Program Brochure 'Click here'   to download program brochure
Contact Information NJ Office - (P) 732.770.4100
Fax - 888.532.0210
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