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DRUG Safety / Pharmacovigilance Internship 2015

January 7th, 2015 Posted by VFreshers


Internship Opportunities forharmacology/Toxicology, Pharmacy, Industrial Pharmacy, Pharmaceutical Chemistry, Public Health/Medicine Freshers in Hyderabad / Secunderabad – January 2015

Job Title : DRUG Safety / Pharmacovigilance : Internship & Workshop Program

No of Posts: 5

Name of Company :UBN Qtech Solutions ( India ) Pvt. Ltd

Experience Required : 0 – 2 yrs

Location of Job : Hyderabad / Secunderabad, United States (U.S)

Job Details :
This is a Home based Internship program, supported with Online material.
Registration and Enrollment is required for attendance to FREE WORKSHOP to know more.

Required :

  1. Extensive knowledge of drug safety and drug development process and procedures
  2. In-depth knowledge of coding principles, submission criteria, regulatory timeline requirements, technical requirements and guidelines
  3. Extensive knowledge of US and ICH safety reporting regulations and guidelines.
  4. Good understanding of IND safety reports, 21 CFR part 11 and HIPPA guidelines.
  5. Performed triage, evaluation and processing of adverse event reports from post marketing and clinical sources in accordance with FDA and ICH guidelines
  6. Working knowledge pertaining to MedDRA and WHO Drug dictionaries.
  7. Proficient in data entry and excellent knowledge of ARGUS safety database.

Job Responsibilities :

Medical Record Extraction :
Extracted relevant Medical Data from the Medical Information provided and entered data into company case template of the case.

Triage:

  1. Reviewed Adverse event Cases and Performed Triage
  2. Reviewed cases for minimum criteria, determine clock start date of case and due date for case and determine type of case.

Case Processing :

  1. Reviewed SAE Report forms.
  2. Created the case in the safety data base (Safety database screens developed In House)
  3. Performed data entry into given drug safety database screens and written narratives

MedDRA Coding:

  • Applied knowledge on MedDRA coding s for issuing queries for all discrepancies found while coding on situational case scenarios on following concepts
  • Investigator Brochure/Labeling/coding information for Coding
  • Coding convention
  • Regulatory status-MSSO
  • Ambiguous laboratory data
  • Missed Concepts for MedDRA coding

Case Narratives:
Generated well written, concise and accurate narratives for both serious and non-serious cases.

Drug Safety Database and Software:
Gained working knowledge pertaining to the functionality and features of Drug Safety database (Oracle Argus).

SAE Reconciliation:

  1. Reviewed SOP for Reconciliation of the Serious adverse event database and SOP for Procedure description for SAE reconciliation
  2. Reconciled serious adverse events reported during the conduct of a clinical research trial in the clinical database with serious adverse events (SAEs) recorded in the Safety Database.
  3. Performed reconciliation to assure that serious events are accurately captured, and interpreted.

Education Required :

Healthcare professionals (e.g. RN, PA, MD, PharmD, Medical Technologist)
OR
Preferred degree in: Pharmacology/Toxicology, Pharmacy, Industrial Pharmacy, Pharmaceutical Chemistry, Public Health/Medicine, Medicine, Nursing,

Description of internship :
The Internship conducted at QPDC is unpaid and Home Based. No relocation is required to participate in this training and Internship program. The Student enrolled in this training will be exposed to various real-time exercises exercise scenarios perform at job in par to real-time and industry standards. At the end of the Internship program, the student will have to write a final objective exam for getting certified.

Upon completion of the training cum internship program each Intern will be provided with a course completion certificate and Post Assistance Training Program . This program includes job preparation support kit (Sample resumes , narrative preparation process, mock interviews with experienced Domain Expert Professionals).

Program Highlights :

  • The Online Package and Individual Programs is backed with following features:
  • Presentations with Voice Over and Material per lesson.
  • Multiple Choice Objectives (MCQs).
  • Real-Time Job based Exercises with Scenarios per lesson.
  • Certificate Exam (Approved by Department of Education , State of NJ).
  • Faculty based Workshops (Per Schedule – spread over 3 months).
  • Subject Matter Queries (Email Support)
  • Career Counseling and Guideline.
  • Post Assistance Training Program.

Description of Company :
Established in 2002, UBN Qtech Solutions (India) Private Limited, a offshore division of Qtech Solutions Inc, (DBA Qtech-Sol Professional Development Center) – QPDC., is a Software Development and Training Organization. QPDC is a Private Vocational School and its Clinical Science Programs are approved by Department of Education and Department of Unemployment and Workforce Development, New Jersey, USA and listed on New Jersey Eligible Training Provider List since year 2011.

We specialize in developing various Job Oriented Training programs primarily focusing towards Clinical Science, Healthcare and SAS Reporting Practices. We help professionals and students to opt for the best career pathway per their education. Qtech’s Staff and Professional advisors bring their scientific, regulatory and informative management experience to deliver timely, accurate, cost-effective programs ,which will help its users to apply the learning direct into business. Our headquarters in New Jersey and regional office in India.

Apply : Email ur cv to qpdc@qtech-solutions.com

Website:http://www.ubnqtechindia.com

For details click : http://jobsearch.naukri.com/job-listings-DRUG-Safety-Pharmacovigilance-Internship-Workshop-Program-UBN-Qtech-Solutions-India-Pvt-Ltd-Hyderabad-Secunderabad-United-States-U-S–0-to-2-years-030115003204?xp=1&qp=internship&srcPage=s

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