Clinical Research Associate / Coordinator (CRAT)

Drug Safety-Pharmacovigilance Data Management (DSPM)

This program is currently being reviewed by the Private Training Institutions Branch (PTIB) of the Ministry of Advanced Education, Skills & Training for approval.

3 Students Enrolled

A Drug Safety-Pharmacovigilance Data and Safety Monitoring and report submissions to Authorities. Responsible for the monitoring, data collection and Analysis and reporting of drug safety information for compliance with drug safety regulations per international markets.
Data Management.

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: Drug Safety / Pharmacovigilance Lessons: 33 Lessons Duration: 08 Weeks / 200 Hours Language: English
Admission Requirements:

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

Institutional Scholarship / Promotion:

Institutional Scholarship / Promotion is available for selected 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.cato 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 Drug Safety / Pharmacovigilance Associate (DSA) Job Titles the candidates can apply after this training program are

DRUG SAFETY MANAGER / PHARMACOVIGILANCE SPECIALIST JOB TITLES
Manager, Drug Safety and Pharmacovigilance Manager, Drug Safety Science
Medical Operations Leader Local Safety Manager (LSM)
Drug Safety Physician Team Lead Quality & Safety
Therapeutic Area Lead Safety Review Specialist – Literature team
Medical Reviewer Medical Safety Manager

 

  • Curriculum Overview

    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 DATA MANAGEMENT

    DRUG SAFETY - PHARMACOVIGILANCE ASSOCIATE 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. 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

    ADVANCED DRUG SAFETY TOPICS

    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

    ADDITIONAL ADVANCED DRUG SAFETY TOPICS

    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


    The EXERCISES covered in the DSPM training program are:

    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

Instructor

qtech-admin

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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 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