New Jersey 732.770.4100

 Drug Safety Data Manager / Pharmacovigilance

A Drug Safety Data Management roles towards project Management and report submissions (DSA) is 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.

The Additional DSA training emphasizes on practical aspects as presentations in the reference to role performed by DSA into industry. See program highlights for more information.






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Admission Requirements
  1. Recommended: Minimum a Bachelor degree in Medicine (MD), Pharmaceutical Chemistry, Pharmacy (PharmD), Nursing (RN).
Curriculum Overview Our program is approachable which provides in-depth knowledge and practical exposure to roles and responsibilities performed by Drug Safety / Pharmacovigilance Data Manager. It gives insight into base topics including but not limited to:
LIST OF TOPICS:
  1. Introduction to MedDRA
  2. MedDRA Coding Guidelines- Modules (1 thru 4)
  3. AE Causality assessments
  4. ICSR Medical Causality assessment
  5. Introduction to Risk Management Plan (RMP)
  6. Introduction to Risk Management Plan (REMS)
  7. Argus Safety End-User Training Modules (1 thru 6)
  8. Product Technical / Quality Complaints (PTC / PQC)
  9. Corrective and Preventative Actions (CAPAs)
  10. Overview of Aggregate Reporting (PSUR/ PBRER)
  11. Overview of Aggregate Reporting - PADER
  12. Overview of Aggregate Reporting - PRAC / DSUR
Teaching Methodology Available as self-paced training (PIP, pure internet program) Course Reading Material (PowerPoint presentations with Voice-over).
Career Opportunity Pathways Drug Safety Associate, Drug Safety Scientist Case Processor, Triage Specialist, Narrative Writer, Medical Record Extractor, Senior Drug Safety 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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