Clinical Research Associate / Coordinator (CRAT)

Pharmacovigilance Assistant (PVAA)

This program does not require approval by the Private Training Institutions Branch (PTIB) of the Ministry of Advanced Education, Skills & Training, since the tuition is less than $4000 CAD. As such, PTIB did not review this program.

3 Students Enrolled

The process of drug development is generally divided into two stages: (1) new lead discovery (preclinical research), and (2) new product development (clinical development). Drug Safety – Pharmacovigilance Assistant can work in Pharmaceuticals, Medical Device, Hospitals and research institutions, such as academic health government agencies and departments, contract research organizations/ centers. Their primary role is to provide support to the Pharmacovigilance team with tasks including, surveillance screens/checks, adverse event intake, questionnaire QC, data entry, preparation, and shipment of case files for adjudication identify safety and risk information, evaluate and report with regulatory authorities.

Our Programs are delivered in 2 Different ways for convenience of student:
• Self-Paced Individual Program (SIP)
– Skill and Job Oriented Certificate programs, delivered as Self-Paced Online with project solutions.
• Self-Paced Blended Program (SBP)
– Skill and Job Oriented Certificate programs, delivered as Self-Paced Online with project solutions. Support thru Email and Phone for queries. Student participates in 7 days Post Training Assistance program for Resume preperation.

Category: Research Assistant Program Lessons: 15 Lessons Duration: 6 Weeks / 175 Hours Language: English
Admission Requirements:

Recommended: An Associate degree in Nursing, Pediatrics, Medicinal Chemistry, Pre-Med, Pharmaceutical Sciences, Pharmaceutics, Pharmacology, Toxicology (or) High School (Health Sciences).

Institutional Scholarship / Promotion:

Institutional Scholarship / Promotion is available for selected students on tuition. We review your education background, certifications, and prior experiences (if applicable), to evaluate your eligibility. Qualified student will be provided with the promo code for scholarship on Tuition.
Please Email your resume to Human Resources qpdc@qtech-solutions.ca to check on your eligibility. We will contact you. Qtech's objective is to provide you the right career pathway and advancement required to meet your career goals.

Learning Outcomes:

The Benefit Student Gains

  1. Upgrading the Knowledge required.
  2. Better Resume Placement for promising jobs.
  3. Low Investment, high learnings
  4. Learn from Anywhere, Anytime at your pace.
  5. Job and Title Based Tasks as followed and Practiced in industry
  6. Applying Concept into Real-time (Policies, governance and tools)
  7. Work on Role Based Tasks followed and Practiced in industry
  8. Mocks and Narratives for Client Discussions
  9. Readiness to work with limited support
Career Pathways

Our objective is to help students to meet the following career pathways. Typical Pharmacovigilance Assistant Job Titles the candidates can apply after this training program are:

PHARMACOVIGILANCE ASSISTANT (PVA)
Drug Safety Assistant Admin Assistant
Argus Data Entry MEDdra Coder
PV Assistant QC Assistant
Inspection Readiness Associate Submission and Documentation
  • Curriculum Overview

    Program is designed by industry experts for students and young professionals. The training program provides in depth knowledge of roles and responsibilities of Drug Safety / Pharmacovigilance Assistant including theoretical aspect of the field.

    PHARMACOVIGILANCE ASSISTANT

    LIST OF TOPICS:

    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 Clinical Trial Protocol
    9. Characteristics of a Case
    10. Sources of Individual Case Reports
    11. Drug Safety Data Extraction and Pre-Processing
    12. Understanding 21 CFR Part 11 and HIPAA
    13. Basic of Coding in Drug Safety
    14. Case Follow up approaches and handling of Cases
    15. Clinical Trial Safety Surveillance
    16. Phase IV Trials and Pharmacovigilance
    17. Case Narratives
    18. SAE Reconciliation
    19. Drug Safety Database and Software
    20. Special Scenarios

Instructor

qtech-admin

5.00 average based on 3 ratings

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Reviews

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

    Maureen D (Texas)

    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.

    Gamal

    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 / Pharmacovigilance Associate training program offered at qtech is very useful for beginners, I liked it and highly recommend others. Currently I am enrolled into Internship program to meet my career goals.

    Sangeetha

    Latha T. (New Jersey)