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.
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Admission Requirements:
Recommended: A Bachelor or Master’s degree in medicine, Nursing (RN), Pharm D, Public Health, Pharmaceutical and Industrial Chemistry, Industrial Pharmacy, Industrial Chemistry.
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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
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Career Pathways
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 |
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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!
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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.
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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.