Virtual – Job Focused Self-Paced Online.
(Along Exercise Solutions – Role based tasks)
Includes resume support, narrative and mock.
Qtech-Learning Management System (Q-LMS)
Save on tuition and gain scholarship
Qtech-Sol is a Clinical Science Training Provider. This course provides Advanced theoretical concepts 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. 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 MedDRA Coding and Guidelines, AE Causality assessments, ICSR Medical Causality assessment, Introduction to Risk Management Plan (RMP), Introduction to Risk Management Plan (REMS), Argus Safety Tool Training, Product Quality Complaints (PTC / PQC), Corrective and Preventative Actions (CAPAs), Overview of Aggregate Reporting (PSUR/ PBRER / PADER/ PRAC / DSUR).
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
- Drug Safety Medical Operations
- Local Safety Manager (LSM)
- Drug Safety Quality & Safety
- Therapeutic Area Lead
- Safety Review Specialist
- Medical Reviewer
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.
|ADDITIONAL DRUG SAFETY-PHARMACOVIGILANCE|
|LIST OF TOPICS:
1. Introduction to MedDRA
2. MedDRA Coding Guidelines- Part 1
3. MedDRA Coding Guidelines- Part 2
4. MedDRA Coding Guidelines- Part 3
5. MedDRA Coding Guidelines- Part 4
6. AE Causality assessments
7. ICSR Medical Causality assessment
8. Introduction to Risk Management Plan (RMP)
9. Introduction to Risk Management Plan (REMS)
|10. Argus Safety End-User Training – Module 1
11. Argus Safety End-User Training – Module 2
12. Argus Safety End-User Training – Module 3
13. Argus Safety End-User Training – Module 4
14. Argus Safety End-User Training – Module 5
15. Product Quality Complaints (PTC / PQC)
16. Corrective and Preventative Actions (CAPAs)
17. Overview of Aggregate Reporting (PSUR/ PBRER)
18. Overview of Aggregate Reporting – PADER
19. Overview of Aggregate Reporting – PRAC / DSUR
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 in an Internship program to meet my career goals.