Advanced Drug Safety Associate Certification and Pharmacovigilance Training
Category:
Drug Safety
 
Duration:
02 Weeks / 90 Hours
 
Price:
$741.79 $482.16 CAD
 
 

Qtech-Sol Advanced DSA Course

Advanced Drug Safety Associate

Qtech-Sol is a Clinical Science Training Provider. This course provides Advanced theoretical concepts to work as Drug Safety 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. 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 :  Advanced Drug Safety Associate
(Role based Lessons – Case Scenarios, Job Tasks with Solutions)
Code :  ADSA
Duration :  2 Weeks / 90 Hours
Delivery : Self-Paced Online with Support.
(Qtech-Sol Learning Management System (Q-LMS)
Course Material : This course contains and delivers 19 Lessons, along with conceptual bonus PMI lessons related to project management.
The ADSA Course contains core lessons as presentation on advanced topics.
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 : $741.79 CAD
Now Only $482.16     BUY NOW
Application Form : APPLY NOW
To complete your enrollment, please email your resume to qpdc@qtech-solutions.ca
Introduction

Qtech-Sol is a Clinical Science Training Provider. This course provides Advanced and Project Management related theoretical concepts 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. Advanced concepts for E2B Monitoring and Reporting and concepts for CAPA, PSUR, RMP, CIOMS Listing, REMS and more. This training will provide the technical skills and practicum needed to gain expertise. Students get exposed to real-time practices and case studies to gain experience on tasks performed on daily basis. Also Includes Audit process and Monitoring of data processed. Insight of GCP-ICH, FDA-EMA SOPs, and Guidelines for conducting Clinical Trials and Pharmacovigilance Business Operations. 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.

Project Management Concepts: This course includes theoretical concepts from the Project Management Institute, PMBOK® as introductory project management course for the clinical research professional. Whether you are looking to become a clinical research project manager, are already in an entry-level project manager role, or a project manager without formal project training, this hands-on program will provide you with project management skills as well as the necessary tools and processes required to successfully manage projects in clinical research settings.

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

This course includes advanced theoretical and Practicum concepts as case studies related to MedDRA Coding and Guidelines, AE Causality assessments, ICSR Medical Causality assessment, Introduction to Risk Management Plan (RMP), Introduction to Risk Management Plan (REMS), Argus Safety Tool Training, Product Quality Complaints (PTC / PQC), Corrective and Preventative Actions (CAPAs), Overview of Aggregate Reporting (PSUR/ PBRER / PADER/ PRAC / DSUR).

An Ideal person must have bachelor’s degree in degree in life science or other health-related discipline to become a DSA. 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 etc. The ideal person works within pharmaceutical or at hospital and research centers.

Examples of job titles to apply
  1. Drug Safety Associate
  2. Drug Safety Coordinator
  3. Pharmacovigilance Associate
  4. Triage Case Processor
  5. Argus Drug Safety Data Entry
  6. Patient Safety Manager
  7. Medical Reviewer
  8. Local Safety Manager

  • 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.

    Qtech 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!

    – Indrani C (Scarborough, Ontario)

    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.

    – Teja K (Brampton, Ontario)

    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.

    – Abigaelle C (York, Ontario )

    Getting Connected

    For additional information please call us on 905.519.0889 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 advanced lessons and concepts as performed by Drug Safety Associate / Coordinator (or) Pharmacovigilance Specialist towards Post Marketing and Surveillance role. 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.

Advanced Drug Safety Associate
ADSA – Advanced DSA Lessons

1.  Introduction to MedDRA

2. MedDRA Coding Guidelines- Part 1

3. MedDRA Coding Guidelines- Part 2

4. MedDRA Coding Guidelines- Part 3

5. MedDRA Coding Guidelines- Part 4

6. AE Causality assessments

7. ICSR Medical Causality assessment

8. Introduction to Risk Management Plan (RMP)

9. Introduction to Risk Management Plan (REMS)

10. Argus Safety End-User Training – Module 1

11. Argus Safety End-User Training – Module 2

12. Argus Safety End-User Training – Module 3

13. Argus Safety End-User Training – Module 4

14. Argus Safety End-User Training – Module 5

15. Product Quality Complaints (PTC / PQC)

16. Corrective and Preventative Actions (CAPAs)

17. Overview of Aggregate Reporting (PSUR/ PBRER)

18. Overview of Aggregate Reporting – PADER

19. Overview of Aggregate Reporting – PRAC / DSUR

Also includes PMI project management concepts for planning and executing Pharmacovigilance projects.

Getting Connected

For additional information please call us on 905.519.0889 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 in an Internship program to meet my career goals.

    Latha T. (New Jersey