This program is designed by industry experts for students and young professionals looking for Entry and career advancement with pharmaceutical drug safety operations. This program provides in-depth understanding of Clinical Protocol and Pharmacovigilance Regulatory practices and Guidelines followed by Pharmaceuticals for Drug safety and Pharmacovigilance Reporting and monitoring process.
Our Programs are delivered in SIP model for convenience of student:
- Self-Paced Individual Program (SIP)
- Skill and Job Oriented Certificate programs, delivered as Self-Paced Online with project solutions.
Recommended: An Associate or bachelor’s degree in Medicine, Nursing, Pharmacy, Public health Biology, Biochemistry, Biotechnology, Chemistry, Clinical Research, Biomedical engineering, Public health, Pharmacology, or toxicology, Medical Device & Technology, Psychology, Sociology and Healthcare Administration.
Please Email your resume to Human Resources firstname.lastname@example.org to check on your eligibility. We will contact you. Qtech’s objective is to provide you the right career pathway and advancement required to meet your career goals. Qualified candidates will have the opportunity to avail of our Post Training Assistance (PTA Program) for getting prepared and finding jobs.
- We adapt guidelines followed by American-FDA (US Food and Drug Administration), European-EMA (European Medicines Agency) and Canadian-Health
- Presentations with voice-over and detailed online material
- Mix of quizzes for practice, quizzes as test, Discussion based questions and various job-related exercises, along with solutions.
- Learn on-demand, upgraded content that helps you stay up do date.
- Applying Concept into Real-time (Policies, governance and tools)
- Earn a Course Completion Certificate to showcase in your resume
|LIST OF LESSONS|
|Overview of Clinical Trial Protocol|
|Phase IV Trials and Pharmacovigilance|
|Understanding of 21 CFR Part 11 and HIPAA|
|ICH Good Clinical Practice Guidelines|
|Drug Safety Regulation and Guidelines|
|Revision of SOPs|
- Fundamentals of Drug Safety in Clinical Trials (FDSA)
- Adverse Events, Recouncilation and Assesments (AERA)
- Advanced Drug Safety Concepts (ADSC)
- Drug Safety Database and Argus Tool (ARGD)
- Drug Safety-Pharmacovigilance Data Processing (DSDP)
- Drug Safety Data and AE Reporting (DSAE)
- Fundamentals of MedDRA (MEDR)