Training as Internship
ID# :Q-IN-2017-PS046
Date Posted : 08-11-2017 (mm-dd-yyyy)
Title : pharmacovigilance quality assurance

Classification: Training program as Internship

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

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 PVQA Package program offered, allows you to focus on securing a career advancement job.

Pharmacovigilance Quality Assurance- Job Oriented Training Program (PVQA)

  1. Pharmacovigilance Quality Assurance (PVQA) - 45 Days
  2. 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 Clinical Research Quality Assurance 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 Pharmacovigilance Quality Assurance at Pharmaceutical, Hospital and Research Organizations, performing quality assurance tasks for Drug Safety Operations and Audit Processes. This Training program is Unpaid Internship and is conducted for 6 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 PVQA task to perform, client settings followed in Industry, team-work and will submit timely the allocated deliverable 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 PVQA Job related hypothetical tasks to gain required experience. The tasks are evaluated and feedback is provided via email.Candidate who cannot participate on-site, can participate from their home as virtual-Internship.

Learning’s Gained during this Training Program

  • Establish and maintain optimal relationships with internal and external stakeholders (ex. PV Operations, PCYC Quality Groups, partner Company Quality and Compliance counterparts).
  • Support in advancing the framework/systems supporting PV Quality and Compliance.
  • To include but not limited to process documents, audit/inspection data, compliance monitoring/reports, contracts, and metrics related to PV Quality and Compliance.
  • Coordinates document control process with new or revised procedures, ensuring document control and training requirements are fulfilled.
  • Participate/support in business partner, vendor, and internal process audits. Support/lead assigned tasks by management.
  • Support Company’s Quality risk-based program related to company activities
  • Collaborate with company management and Quality Assurance (QA) to prepare for, participate in, and track outcomes (findings) from audits/inspections.
  • Contributes to the review of all findings related to drug safety activities from audits/regulatory inspections (internal company and PV TPs). Ensure CAPAs are developed and implemented when appropriate.
  • Support the development and reporting of company metrics and monitor efficiency, quality and adherence to regulatory and contractual obligations with TPs. Enhance method of tracking TP compliance to safety agreements.
  • Maintain a process to ensure TP contracts contain appropriate adverse event reporting language.
  • Collaborate with company, QA and other cross functional departments to develop/maintain quality system-related SOPs/Work Instructions/Forms.
  • Support management of DSP nonconformance procedures, including identification, investigation, tracking/trending and reporting. Perform investigations and prepare nonconformance documentation.
  • Contributes to process improvement and educational initiative.
  • Provide training on PV Quality and Compliance related activities.
  • Perform other activities as directed by management.
 
Education Background Required : Bachelors / Master’s Degree in: Medicine, Nursing (RN), PharmD, Pharmacy, Public Health, Pharmaceutical and Industrial Chemistry.
 
Experience : 0 years
 
Application End Date: 11-30-2017 (mm-dd-yy)
 

Please forward Your resumes along with ID to hrs@qtech-solutions.com

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