Certificate Course in Pharmacovigilance and Clinical Research

Applicant should have passed B.Pharm, M.Pharm, Pharm.D, Nursing, BSC, MSC, B.Tech Biotech, M.Tech Biotech, BDS, MDS, BHMS, BAMS, BPT, MBBS.

Program Details:

Clinical Research Modules

1. Drug Discovery
2. Overview of Clinical Research
3. Regulations & Guidelines in Clinical Research
4. Roles & Responsibilities of Key Stakeholders
5. Preparation & Planning of Clinical Trials
6. Essential Documentation in Clinical Research & Regulatory Submission
7. Study Start Up Process
8. Clinical Monitoring Essentials
9. Compliance, Auditing & Quality Control in Clinical Research

Pharmacovigilance Modules

1. Overview of Clinical Research
2. Pharmacology – General Principles
3. Introduction to Pharmacovigilance
4. Pharmacovigilance Regulations
5. Hands on Training on Case Processing and Report Generation
6. Safety Reporting and Processing ICSR
7. Aggregate Reports, Signal Detection & Risk Management
8. Documents in Pharmacovigilance
9. Audits & Inspections
10. Advanced Pharmacovigilance & Analytics

Entry Level Career Options

1. Clinical Research Coordinator
2. Clinical Trial Assistant
3. Clinical Research Associate
4. Pharmacovigilance Associate
5. Drug Safety Associate
6. Pharmacovigilance Officer
7. Clinical Data Associate
8. Clinical Data Analyst
9. Junior Data Analyst
10. Trainee Junior Data Analyst