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 theoretical aspect of the field and exposure to variety exercises based on industry requirements.
Our Programs are delivered in 3 Different ways for convenience of student:
• Pure Internet Program (PIP)
– A Self-Paced Online Program with Email Support
• Blended Internet Program (BIP)
– A Self-Paced Online Program with Email Support Provided (WebEx Online Classes)
• Blended Classroom Program (BCP)
– On-Site Faculty based Classes, along with Email Support (On-Site Class)
|Lessons: 22 Lessons||Duration: 06 Weeks / 175 Hours||Language: English|
Drug Safety- Pharmacovigilance Associate program is Approved by New Jersey Department of Education and Department of Labor and Workforce, United States.
Recommended: A Bachelor or master’s degree in medicine, Nursing (RN), Pharm D, Public Health, Pharmaceutical and Industrial Chemistry, Industrial Pharmacy, Industrial Chemistry
Institutional Scholarship / Promotion is available for selected on tuition. We review your education background, certifications, and prior experiences (if applicable), to evaluate your eligibility. Qualified student will be provided with the promo code for scholarship on Tuition.
Please Email your resume to Human Resources email@example.com to check on your eligibility. We will contact you. Q-tech’s objective is to provide you the right career pathway and advancement required to meet your career goals.
The Benefit Student Gains
1) Upgrading the Knowledge required.
2) Better Resume Placement for promising jobs.
3) Low Investment, high learnings
4) Learn from Anywhere, Anytime at your pace.
5) Job and Title Based Tasks as followed and Practiced in industry
6) Applying Concept into Real-time (Policies, governance and tools)
7) Work on Role Based Tasks followed and Practiced in industry
8) Mocks and Narratives for Client Discussions
9) 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 / PHARMACOVIGILANCE JOB TITLES|
|Drug Safety Associates||Patient Safety Associate|
|Drug Safety Assistant||Associate PV|
|Case Processor||Medical Record Extractor|
|Drug Safety Associate / AE Coordinator||Triage Processor|
|Drug Safety Reporting||Data Entry Specialist|
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:
1. Introduction to Clinical Research
2. Drug Development Process
3. Introduction to Drug Safety / Pharmacovigilance
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 Clinical Trial Protocol
9. Characteristics of a Case
10. Sources of Individual Case Reports
11. Drug Safety Data Extraction and Pre-Processing
12. SOP Development
13. Communication with Cross Functional Team
14. Understanding 21 CFR Part 11 and HIPAA
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
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
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