mega888 apk Drug Safety Data Management | DSA Training
Course:  Drug Safety-Pharmacovigilance Management
Code:  DSPM
Delivery:
Virtual – Job Focused Self-Paced Online.
(Along Exercise Solutions – Role based tasks)
Post Training Assistance (PTA):
Includes resume support, narrative and mock.
Duration:  14 Weeks / 450 Hours
Online Access :
Qtech-Learning Management System (Q-LMS)
Fees : $3,442.35 CAD
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Course Description:

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.

This program includes theoretical concepts from the Project Management Institute, PMBOK® as introductory project management course for the drug safety professional. Whether you are looking to become a drug safety associate or E2B safety project manager, this program is designed for 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.

A Drug Safety Associate is responsible for assessing the safety of pharmaceuticals drugs once they’re on the market. Using standardized guidelines, they determine whether the medication causes any adverse reactions in patients and report their findings back to the pharmacovigilance department. 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.

  • Admission Requirements:

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

  • 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
  • Career Pathways

    The program objective is to help Drug Safety-Pharmacovigilance Professionals to meet the following career pathways. After completing this certificate program, students can apply for below open job titles, based on highest education background and prior experiences (if any).

DRUG SAFETY MANAGER / PHARMACOVIGILANCE SPECIALIST JOB TITLES
  • Drug Safety Associate
  • Pharmacovigilance Associate
  • Triage Case Processor
  • Argus Drug Safety Data Entry
  • Drug Safety Coordinator
  • Patient Safety Manager
  • Medical Reviewer
  • Local Safety Manager

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 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

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

  • 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

  • Category:
    Drug Safety
  • Duration:
    14 Weeks
  • Price:
  • Language:
    English