Virtual – Job Focused Self-Paced Online.
(Along Exercise Solutions – Role based tasks)
Includes resume support, narrative and mock.
Qtech-Learning Management System (Q-LMS)
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Qtech-Sol is a Clinical Science Training Provider. This course provides Foundation learning to work as DSA 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. 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. 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 and Practicum concepts as case studies related to Introduction to Drug Safety / Pharmacovigilance, Introduction to Adverse Events, ICH-Good Clinical Practice Guidelines, Drug Safety Regulation and Guidelines, Characteristics of a Case, ICSR – Individual Case Safety Reports, Drug Safety Data Extraction and Pre-Processing, SOP Development, Basics of Coding in Drug Safety, Case Follow up approaches and handling of Cases, Case Narratives, SAE Reconciliation, Argus Drug Safety Database and Software, Handling Special Scenarios.
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.
In a life-threatening case, or in the case of death, DSAs are given 1-2 business days to process the necessary information and pass it onto other teams. Other medical cases including hospitalization, significant disability, congenital anomaly or other medically important events require this process to be completed in 2-7 days.
Recommended: A Bachelor or Master’s degree in Medicine, Nursing (RN), Pharm D, Public Health, Pharmacy, Pharmaceutical or Industrial Chemistry.
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
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 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 ASSOCIATE|
|LIST OF TOPICS:
THEORETICAL ASPECT OF THE FIELD
1. Introduction to Clinical Research
2. Drug Development Process
3. Introduction to Drug Safety /
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
12. SOP Development
13. Communication with Cross
14. Understanding 21 CFR Part 11
|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
LIST OF REAL TIME CASES:
PRACTICAL EXPOSURE TO DAILY
ROLES AND RESPONSIBILITIES
CASE 1. Introduction to Adverse Events CASE 2. Role of DSA / PVA
CASE 3. Characteristics of Case
CASE 4. Medical Record Extraction
CASE 5. Basics of Coding
CASE 6. Triage
CASE 7. Case Narratives
CASE 8. SAE Reconciliation
CASE 9. Drug Safety Database and Software
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!
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.
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.