New Jersey 732.770.4100

 Advanced Drug Safety Associate Training

A Drug Safety Associate (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 Advanced DSA training emphasizes on practical aspects in the reference to role performed by DSA into industry. See program highlights for more information.






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Program Highlights

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Admission Requirements
  1. Recommended: minimum a Bachelor degree in Pharmaceutical Chemistry, Public Health, Medicine, Pharmaceutical Management, Clinical Research, Pharmacy, Nursing, Pharmacology, Toxicology, Industrial Pharmacy or Industrial Chemistry
  2. Completed DSA training or work experience
Curriculum Overview The course is designed for experienced professionals to add new skills set and therefore prior training or relevant experience is required. The Advanced DSA provides hands on experience to diverse advanced tasks performed by DSA into Industry. During the program students will:
  1. explore practical aspect of the subject;
  2. have an opportunity to get hands on experience on the concepts learned in DSA training,
  3. gain exposure to roles and responsibilities performed by DSA into industry along with advanced learning of different tasks in reference to real time data and work flow pattern to be followed.
  4. In particular:
    1. Medical Record Extraction
    2. Adverse Events Case Processing
    3. CIOMS Line Listing
    4. Case processing and FDA Reporting for Medical Devices
    5. Revision of SOP Quality Control Procedure
    6. SAE Reconciliation
    7. PSUR - Periodic Safety Update Reporting
    8. Triage
    9. Data Entry
    10. Signal Detection
    11. Labeling Edit check
    12. Quality Control Procedure
    13. Resolution of queries of pending cases
    14. SUSAR - Suspected Unexpected Serious Adverse Reaction
Teaching Methodology Available as self paced training (PIP, pure internet program)
Course Reading Material (PowerPoint presentations and Exercises)
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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