The course provides a thorough Foundation, Advanced and Project Management related concepts focusing clinical trials, drug development, Study design, Project Management, and Monitoring concepts of Clinical Sciences in reference to roles and responsibilities performed by Clinical Research Associate. The concepts include protocol development, assessment and reporting of adverse events and explain GCP-ICH guidelines along with other necessary regulatory information. The course emphasizes understanding of the science and the expectations of initiating, conducting, monitoring, and managing clinical trial-related work. This training will develop the technical skills and knowledge pertaining to the roles and responsibilities of CRA – In House. Students will get exposure to real-time practices pertaining to Case Report forms (CRFs), Trial Master File (TMF), Clinical Trial Protocol, Clinical Trial Budget, and Audit. The course curriculum is designed to give an edge to obtain job opportunities in the clinical research field.
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. The student participates in 7 days Post Training Assistance program for Resume preparation.
Recommended: A Bachelor or Master’s degree in medicine, nursing (RN), Pharm D, Public Health, Pharmaceutical and Industrial Chemistry, Industrial Pharmacy, 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
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 Associates
- Drug Safety Assistant
- Associate PV
- Case Processor
- Medical Record Extractor
- Drug Safety Associate / AE Coordinator
- Triage Processor
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.