Drug Safety Certification and Pharmacovigilance Training
Category:
Drug Safety
 
Duration:
6 Weeks / 175 Hours
 
Price:
$1,094.00 $711.00
 
 

Qtech-Sol DSA Certificate Course

Drug Safety Associate

Qtech-Sol is a Clinical Science Training Provider. This is foundation course 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.

Course Name :  Drug Safety Associate
(Role based Lessons – Case Scenarios, Job Tasks with Solutions)
Code :  DSAT
Duration :  6 Weeks / 175 Hours
Delivery : Self-Paced Online with Support.
(Qtech-Sol Learning Management System (Q-LMS)
Course Material : This course contains and delivers 22 Lessons.
Each Lesson contains various delivery modes as presentation with voice over, course reading material (chapters), Quizzes for Practice (15 Set) and Test (10 Set), Short Questions, Role based Tasks (Exercises, along with solutions).
Course Brochure : Download BROCHURE
Course Demo : Register for COURSE DEMO
Fill out Registration form and select module name Clinical Sciences and select course “Drug Safety Associate”.
You will receive an email with weblink to self-activate your demo course.
Upon activation will have access to 4 lessons for next 5 days.
Online Discussion : Book your slot for a personalized ONE-O-ONE discussion with us. You will receive an online invite to participate via email.
Fees : $1,094.00 USD
Now Only $711.00    BUY NOW
Application Form : APPLY NOW
To complete your enrollment, please email your resume to qpdc@qtech-solutions.com
Introduction

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.

In a life-threatening case, or in the case of death, DSAs are given 1-2 business days to process the necessary information and pass it onto other teams. Other medical cases including hospitalization, significant disability, congenital anomaly or other medically important events require this process to be completed in 2-7 days.

Course Enrollment process

Qtech-Sol offers self-paced online courses. Student get started with the course when they are ready. They must complete the online application, pay applicable tuition and submit required credentials. Student must submit their resume and copy of highest degree certificate obtained. These documents are used to validate the student’s name on certificate, contact information, course enrolled and their education eligibility to participate.

Start to Finish Steps:
  1. Submit Online Application
  2. Pay applicable tuition (Shopping cart)
  3. Email credentials required
  4. Receive Course Activation email
  5. Obtain access to Course and Solution bank (LMS)
  6. Receive support for subject related queries.
  7. Submit Course task deliveries per schedule shared
  8. Take Final exam upon completing he course
  9. Obtain Course completion certificate and transcript
  10. Get Started with PTA program for next steps
Gaining experience

An Ideal person must have bachelor’s degree in degree in life science discipline (Medicine, Nursing, Pharmacy or Chemistry) to become a Drug Safety Associate or Drug Safety Coordinator. Qtech-Sol DSA Coursework is not wet lab experience, these are computer related roles performed using clinical data and tools, to support the progress of clinical trials being conducted. Person must have basic computer knowledge and works with Microsoft Word, Excel, Notepad, PowerPoint, AE Database tools etc. The ideal person works within pharmaceutical or at hospital and research centers.

This course emphasizes about drug safety and pharmacovigilance along with project management concepts. Contains lessons on Introduction to Clinical Research, Drug Development Process, Introduction to Drug Safety / Pharmacovigilance, Role of DSA / PVA (Trials), Introduction to Adverse Events, ICH-Good Clinical Practice Guidelines, Drug Safety Regulation and Guidelines, Overview of the Clinical Trial Protocol, Characteristics of a Case, Sources of Individual Case Reports (ICSR), Drug Safety Data Extraction and Pre-Processing, SOP Development, Communication with Cross Functional Team, Understanding 21 CFR Part 11 and HIPAA, Basic of Coding in Drug Safety, Case Follow up approaches and handling of Cases, Clinical Trial Safety Surveillance, Phase IV Trials and Pharmacovigilance , Case Narratives, SAE Reconciliation, Drug Safety Database and Software, Reporting under Special Scenarios. The course curriculum is designed to give an edge to obtain job opportunities in the drug safety-pharmacovigilance field with Pharmaceuticals, Biotech, Medical Device, Clinical Research Organizations (CROs) and with Research Clinics.

Examples of job titles to apply
  1. Drug Safety Associate
  2. Drug Safety Assistant
  3. Pharmacovigilance Associate
  4. AE Case Processor
  5. Medical Record Extractor
  6. Patient Safety Coordinator

  • Eligible Education:

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

    Post Training Assistance

    Your resume is front face to hiring recruiters and organizations to pre-screen or call for an interview. With competition out in market, does your resume meet the requirements. Contact us to participate in our Post Training Assistance(PTA) program for resume build, interview narratives, and mock. It is as well important to know, the current hiring organizations in your area, open positions available, salary range, fitness of resume to apply and many more. During this PTA program you will have opportunity to discuss with our course specialist to learn and discover opportunities in small steps. We shall work together as team to achieve this goal.

  • 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
  • Professional organizations

    Professional organizations and associations are membership-based groups comprised of people working in a similar field. They can be helpful resources for students to learn more about a field, develop connections and discover related opportunities.

    Check out World-Wide Clinical Resource Information. Follow the resource links to learn what’s happening around the world on current news and updates about Clinical trials, Regulatory, CDM and Pharmacovigilance.

    Reviews

    Qtech-Sol has trained since 2000, many candidates with different education background and skills. Few of them are currently working as directors in top MNC companies.

    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)

    It was a very interesting CRA training course. Topic, professional presentation, Quiz and test, makes the difference between a good training session and a GREAT training session. I like the competent materials course.

    – 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)

    Getting Connected

    For additional information please call us on 732.770.4100 or ENQUIRE. One of our course specialists will contact you at earliest possible.

Curriculum Overview

This course is designed by industry experts meeting job and title-based learnings needed for students and young professionals to get into jobs. The training provides in depth knowledge of roles and responsibilities of Drug Safety Associate/ Coordinator. The curriculum includes theoretical and practical aspect of the role and tasks performed on day-to-day basis, along with exposure to various exercises per industry requirements.

Drug Safety Associate / Coordinator
DSAT – Basic Drug Safety Lessons

1. Introduction to Clinical Research

2. Drug Development Process

3. Introduction to Drug Safety / Pharmacovigilance

4. Role of DSA / PVA (Trials)

5. Introduction to Adverse Events

6. ICH-Good Clinical Practice Guidelines

7. Drug Safety Regulation and Guidelines

8. Overview of the Clinical Trial Protocol

9. Characteristics of a Case

10. Sources of Individual Case Reports

11. Drug Safety Data Extraction and Pre-Processing

12. SOP Development

13. Communication with Cross Functional Team

14. Understanding 21 CFR Part 11 and HIPAA

15. Basic of Coding in Drug Safety

16. Case Follow up approaches and handling of Cases

17. Clinical Trial Safety Surveillance

18. Phase IV Trials and Pharmacovigilance

19. Case Narratives

20. SAE Reconciliation

21. Drug Safety Database and Software

22. Special Scenarios

Getting Connected

For additional information please call us on 732.770.4100 or ENQUIRE. One of our course specialists will contact you at earliest possible.

  • 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)