Drug Safety Data Management Certification and Pharmacovigilance Training
Category:
Drug Safety
 
Duration:
12 Weeks / 450 Hours
 
Price:
$2,540.75 $1,524.45 (CAD)
 
 

Qtech-Sol DSM Certificate Course

Qtech-Sol DSM Certificate Course

Qtech-Sol is a Clinical Science Training Provider. This course provides a thorough Foundation, Advanced and Project Management related concepts to become a Drug Safety-Pharmacovigilance Data Management Specialist or Senior Drug Safety Associate, focusing on tasks while performing clinical trial studies, pharmacovigilance reporting, safety project management and medical review procedures. This is a job and title focused program. The course emphasizes about role of DSA towards to operate in GxP compliance towards case processing (ICSR), triage, aggregate reporting, medical monitoring, audit and reporting of adverse events observed and captured during clinical trials and post marketing surveillance phase. This course also includes tool concepts of MedDra, and ARGUS database used for reporting details. The course curriculum is designed to give an edge to obtain job as DSA with Pharmaceuticals, Biotech, Medical Device, Clinical Research Organizations (CROs) and with Research Clinics.

Course Name :  Drug Safety-Pharmacovigilance Data Management
(Role based Lessons – Case Scenarios, Job Tasks with Solutions)
Code :  DSPM
Duration :  12 Weeks / 450 Hours
Delivery: Self-Paced Online with Support.
(Qtech-Sol Learning Management System (Q-LMS)
Course Material : This course contains and delivers 46 Lessons.
This course contains 3 modules spread across 12 weeks to complete.
DSAT – Basic DSA Course – 6 Weeks
DSAP – Drug Safety Tasks as Projects – 4 Weeks
ADSA – Advanced DSA Lessons – 2 Weeks
DSAT Course contains lessons with 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).
The DSAP and ADSA Courses contains lessons with various delivery modes as presentation and Role based Tasks (Exercises, along with solutions).
Course Brochure : Download BROCHURE
Course Demo : Register for COURSE DEMO
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 : $2,540.75 CAD
Now Only $1,524.45     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 a thorough Foundation, Advanced and Project Management related 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

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.

The basic 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.

The project tasks as exercises is shared along with task document as hypothesis for perform Medical Record Extraction, Adverse Events Case Processing, CIOMS Line Listing, Case processing and FDA Reporting for Medical Devices, Revision of SOP, Quality Control Procedure, SAE Reconciliation, Triage, Data Entry, Signal Detection, Labeling Edit check, Quality Control Procedure, Resolution of queries of pending cases, SUSAR – Suspected Unexpected Serious Adverse Reaction Tasks per Guidelines shared.

The advanced topics shared in this course are MedDRA Coding Guidelines, AE Causality assessments, Introduction to Risk Management Plan (RMP), Introduction to Risk Management Plan (REMS), Argus Safety End-User Training, Product Technical / Quality Complaints (PTC / PQC), Corrective and Preventative Actions (CAPAs), Overview of Aggregate Reporting (PSUR/ PBRER), Overview of Aggregate Reporting – PRAC / DSUR
of a Successful Drug and Patient reporting and for monitoring of New and Existing drug compliance.

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.

    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)

    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 in depth knowledge of roles and responsibilities of Drug Safety Associate / Coordinator (or) Pharmacovigilance Specialist. 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-Pharmacovigilance Data Management
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

DSAP – Drug Safety Tasks- Projects

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

ADSA – Advanced DSA Lessons

1. Introduction to MedDRA

2. MedDRA Coding Guidelines- Modules 1 thru 4

3. AE Causality assessments

4. Introduction to Risk Management Plan (RMP)

5. Introduction to Risk Management Plan (REMS)

6. Argus Safety End-User Training Modules 1 thru 6

7. Product Technical / Quality Complaints (PTC / PQC)

8. Corrective and Preventative Actions (CAPAs)

9. Overview of Aggregate Reporting (PSUR/ PBRER)

10. Overview of Aggregate Reporting – PRAC / DSUR

Job Focused Tasks with Solution

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

6. Quality Control Procedure

7. SAE Reconciliation

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

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 into an Internship program to meet my career goals.

    Latha T. (New Jersey