The process of drug development is generally divided into 2 stages: (1) New lead discovery (Preclinical Research), and (2) New product development (Clinical Development). Drug Safety – Pharmacovigilance Associate can work in Pharmaceuticals, Medical Device, Hospitals and research institutions, such as academic health government agencies and departments, contract research organizations/ centers. Their primary role is to identify safety and risk information, evaluate and report with regulatory authorities. The training program provides in-depth knowledge of roles and responsibilities of Drug Safety / Pharmacovigilance Specialist including the theoretical aspects of the field and exposure to various exercises based on industry requirements.
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 :
- 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
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.