Jobs Opening
Position ID :Q-IN-2017-PS038
Date Posted : 03-16-2017 (mm-dd-yyyy)
Jobs Title : Drug Safety - Pharmacovigilance Associate - Intern
No of Openings : 4

Job Classification: Internship

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

Job Duties

This Training as Internship program 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 Unpaid Internship is conducted for 12 Weeks to Fresh and Alumni Students. Selection for Internship is based on GPA and Interview performance. Interns will have the option to participate in person at Somerset, NJ or attend remotely. Students attending the Internship remotely must plan to attend classes thrice a week for minimum 3 hours/ day via GoTo Meeting / WebEx sessions. The sessions will educate the Intern on the Drug Safety tasks to perform, client settings followed in Industry and will be allocated tasks for submission. During Internship, the candidate will have access to Qtech Proprietary forms, data and related presentations. The Intern will be exposed to various Job related hypothetical tasks to gain experience. The tasks are evaluated to provide feedback to Intern as part of the learning gained. Interns who have successfully completed the Internship, will be provided a certificate of completion. Qtech is an equal opportunity employer and E-Verified with Immigration (USCIS). Our Placement division supports various pharmaceutical, healthcare and financial firms, by providing staffing resources meeting cost efficiency, time saved and commitment to their hiring needs. Successful Intern, will be provided an opportunity to work at our client sites on contract as full-time employee of Qtech with benefits.

Learning’s Gained during this Internship / Duties

  • 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 : 0-2 years
Application End Date: 06-16-2017 (mm-dd-yy)

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