Training as Internship
ID# :Q-IN-2017-PS051
Date Posted : 08-11-2017 (mm-dd-yyyy)
Title : Drug Safety Associate

Classification: Training program as Internship

Location : On-Site
Director Operations
Qtech Solutions Inc.
3 Executive Drive, Suite 320
Somerset, New Jersey USA 08873
Phone : 732-770-4100 Fax: 888-532-0210
Email :

Training Program

Qtech-Sol Training division doing business as Qtech-Sol Professional Development Center (QPDC) is a Private Vocational School and its Clinical Science programs are approved by New Jersey State - Department of Education and New Jersey Department of Labor and Workforce Development. We primarily engage in offering an array of short duration certificate courses for corporate, professionals and students. Our DSAT Package program offered, allows you to focus on securing a career advancement job.

DSA Certification and Job Oriented Program (DSAT)

  1. Drug Safety Associate (DSAT) - Certificate Program - 45 Days
  2. Advanced Drug Safety (ADSA) - 30 Days (Bonus)
  3. Drug Safety Data Management (AADS) - 30 Days (Bonus)
  4. Post Training Assistance (Resume Prep, Narratives, and Mock Session) - 15 Days

This program allows you to better place your profile with clients for possible jobs. The job market requires experience and understanding of Drug Safety Operations and the Job tasks performed. Qtech-Sol package program, will provide the required experience to jump-start.

This Training Program as Internship provides students hands-on about the various tasks and duties performed by Drug Safety / Pharmacovigilance Associate Professional at Pharmaceutical, Hospital and Research Organizations towards conduction and project management tasks of Clinical Medical Safety and Trial Operations. This Training program is Unpaid Internship and is conducted for 12 Weeks to Fresh and Alumni Students. Selection of Student is based on education background and GPA, subject to Interview performance. Student will participate into this program remotely. Students attending the Training program must plan to spend minimum 4 hours/ day to submit the deliverables per schedule. The lessons will educate the student on the DSA task to perform, client settings followed in Industry, team-work and submit timely the allocated deliverable tasks as part of this learning. During this Training Program, the candidate will have access to Qtech Proprietary forms, data and related presentations. The Student will be exposed to various DSA Job related hypothetical tasks to gain required experience. The tasks are evaluated and feedback is provided via email. Candidates who have successfully completed the program will be provided a certificate of completion. The student will take a final certificate exam at the end of this training program. Candidate who cannot participate on-site, can participate from their home as virtual-Internship.

Learning’s Gained during this Training Program

  • Introduction to Clinical Research
  • Drug Development Process
  • Introduction to Drug Safety
  • Role of DSA (Trials)
  • Introduction to Adverse Events
  • ICH-Good Clinical Practice Guidelines
  • Drug Safety Regulation and Guidelines
  • Overview of Clinical Trial Protocol
  • Characteristics of a Case
  • Sources of Individual Case Reports
  • Drug Safety Data Extraction and Pre-Processing
  • SOP Development
  • Communication with Cross Functional Team
  • Understanding 21 CFR Part 11 and HIPAA
  • Basic of Coding in Drug Safety
  • Case Follow up approaches and handling of Cases
  • Clinical Trial Safety Surveillance
  • Phase IV Trials and Pharmacovigilance
  • Case Narratives
  • SAE Reconciliation
  • Drug Safety Database and Software
  • Special Scenarios
Education : Medicine, Nursing (RN), PharmD, Pharmacy, Public Health, Pharmaceutical and Industrial Chemistry.
Experience : 0 years
Application End Date: 11-30-2017 (mm-dd-yy)

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