Pharmacovigilance | Role Based Training | DSA
Course:  Drug Safety Projects (Role based tasks)
Code:  DSAP
Delivery:
Virtual – Job Focused Self-Paced Online.
(Along Exercise Solutions – Role based tasks)
Post Training Assistance (PTA):
Includes resume support, narrative and mock.
Duration:  6 Weeks / 175 Hours
Online Access :
Qtech-Learning Management System (Q-LMS)
Fees : $1009.00 USD
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Course Description:

Qtech-Sol is a Clinical Science Training Provider. This course provides projects and hypothetical tasks as learning to work as DSA or Pharmacovigilance Associate. This is a job and title focused program focusing on Drug Safety and Pharmacovigilance tasks performed during Clinical Trial and Long-Term Phase IV (Post-Marketing Surveillance) studies. This is a job and title focused program. The course emphasizes about Case Registry, Triage, Argus Data Entry (Case Studies, ICSR), QA/QC , Medical Review and Submissions of E2B Safety data with regulatory authorities. The course curriculum is designed to give an edge to obtain job opportunities in the drug safety field with Pharmaceuticals, Biotech, Medical Device, Clinical Research Organizations (CROs) and with Research Clinics.

This program includes theoretical and Practicum concepts as case studies related to Role of DSA, Introduction to Adverse events, Basics of Coding in Drug Safety. Argus Medical Record Extraction, Triage, Characteristics of a Case, Case Processing, Argus Data Entry, Case Narratives, Drug safety Database and Software, CIOMS Line Listing, Signal Detection, Drug Labeling and Edit Checks, Quality Control Procedures, SAE Reconciliation, Resolution of Queries for Pending Cases, PSUR Reporting and SUSAR.

Being a significant part of the pharmacovigilance and safety services (PVSS) department, a Drug Safety Associate (DSA) is a key job profile for drug safety management in clinical trials and post marketing surveillance (PMS). Once a drug has been marketed the work for a DSA begins after. As soon as an alert of a serious adverse event (SAE) is raised the clock starts and sets into motion the necessary tasks that need to be completed to process the events.

  • Admission Requirements:

    Recommended: A Bachelor or Master’s degree in Medicine, Nursing (RN), Pharm D, Public Health, Pharmacy, Pharmaceutical or Industrial Chemistry.

  • Learning Outcomes:
    The Benefit Student Gains
    • Upgrading the Knowledge required.
    • Better Resume Placement for promising jobs.
    • Low Investment, high learnings
    • Learn from Anywhere, Anytime at your pace.
    • Job and Title Based Tasks as followed and Practiced in industry
    • Applying Concept into Real-time (Policies, governance and tools)
    • Work on Role Based Tasks followed and Practiced in industry
    • Mocks and Narratives for Client Discussions
    • Readiness to work with limited support
  • Career Pathways

    The program objective is to help Drug Safety-Pharmacovigilance Professionals to meet the following career pathways. After completing this certificate program, students can apply for below open job titles, based on highest education background and prior experiences (if any).

DRUG SAFETY / PHARMACOVIGILANCE JOB TITLES
  • Drug Safety Associates
  • Drug Safety Assistant
  • Pharmacovigilance Associate
  • AE Case Processor
  • Medical Record Extractor
  • Patient Safety Coordinator
  • Triage Processor
  • E2B Case Reporting and Submissions

Designed by industry experts for students and young professionals. The training program provides in depth knowledge of roles and responsibilities of Drug Safety / Pharmacovigilance Specialist including theoretical aspect of the field and exposure to variety exercises based on industry requirements.

Drug Safety-Pharmacovigilance-Role based Projects(DSAP)
LIST OF TOPICS:

THEORETICAL ASPECT OF THE FIELD

1. Role of DSA

2. Introduction to Adverse events

3. Basics of Coding in Drug Safety

4. Medical Record Extraction

5. Triage

6. Characteristics of a Case

7. Case Processing

8. Data Entry

9. Case Narratives

10. Case Follow up and Handling of Cases

11. Drug safety Database and Software

12. CIOMS Line Listing

13. Signal Detection

14. Case Processing and FDA Reporting-Medical Device

15. Drug Labeling and Edit Checks

16. Revision of SOPs

17. Quality Control Procedures

18. SAE Reconciliation

19. Resolution of Queries for Pending Cases

20. PSUR Reporting

21. SUSAR

  • The program gave me an in-depth understanding of the role of a DSA in the Clinical Research and Pharmacovigilance department. With the practical examples and lectures from professionals, I gained a clear understanding of the practical applications needed for work. Very good course work!

    Ramya I (New Jersey)

  • The best part about DSA training is presentations which clearly mention the important and key points that are helpful for building basics in the subject. I found the exercises helpful in understanding the format on how to fill the forms and analyzing the data which will be useful in real-time for me.

    Kinjal C (Virginia)

  • I am a Medical Science graduate. This Certificate training helped me to understand the Job-related work process better. The Drug Safety Associate training program offered at Qtech is very useful for beginners, I liked it and highly recommend others. Currently, I am enrolled into an Internship program to meet my career goals.

    Latha T. (New Jersey)

  • Category:
    Drug Safety
  • Duration:
    6 Weeks
  • Price:
  • Language:
    English