Background information

With financial support from the Global Fund Round 10, Hanoi University of Pharmacy implements Pharmacovigilance Component in Health System Strengthening Project. In this component, Vietnamese pharmacovigilance system is assisted to have comprehensive development. The component project aims at implementing a national pharmacovigilance network - implementing a national spontaneous reporting system as well as establishing a feedback system that would contribute towards the assurance of safety and efficacy of medicine use

At present, the project starts to conduct three researches/studies on (1) medicine utilization study (2) the reduction of medicines related to mortality and morbidity(3) the percentage of reported cases of adverse events that have been appropriately managed in regional centers, sentinel hospitals and PHPs. These studies will contribute to evaluate drug-related problems and status of medicine use in the health system aiming at improving rational use of medicines among healthcare professionals.  

Objectives of Assignment

The overall objective or output of this assignment is to build up a comprehensive protocol for each research (one applicant apply for one research).

Job description

Provision of support services: The Consultant will work with close consultation with the Technical Group of the project.

The following are the specific activities to produce the expected deliverable by the consultant:

I.            Provide a detail protocol of a medicine utilization study which includes at least following sections:

        1.       Background:

        - Datareview/ Literature/ Reference

2.       Study design: type of the study

3.       Data collection: type of data, criteria of data,  sample size calculation, form of questionnaires to collect data, SOP for data collection, toolkit of data quality assurance

4.       Patient selection (if applicable): selection and withdraw, inclusion/exclusion criteria, medication        information

5.       Methods: study parameters/endpoints (main and secondary endpoints)

6.       Study procedure/Statistic analysis: statistic methods, statistic software

7.       Administrative aspects

II.            Provide the study manuals/user guides

III.            Training for the interviewers who will collect data

IV.            Provide technical assistance in study performance: consulting in data collection, data processing, data analysis; Provide study quality assurance services.

V.            Responsible for writing study reports

(Note: (1) medicine utilization study: proposing model of retrospective study design  (2) the reduction of medicines related to mortality and morbidityand (3) the percentage of reported cases of adverse events that have been appropriately managed in sentinel sites: proposing model of prospective study design  (monitoring patients from 3 – 6 months)

The expected results of this consultant are

(1)     Produce the protocol; (2) Produce data collection toolkits; (3) Produce standard of procedures of study quality assurance; (4) Produce a report on development process; (5) Produce user manual/user guide and  training materials for interviewers; (6) Produce final study reports

General requirements

·      Demonstrated solid experience on designing and developing study protocol in medicine utilization and drug-related problems

·      Excellent writing, communication and presentation skills in English

·      Proven track record of having worked with Pharmacovigilance (PV) initiatives is an advantage

Education:

Master Degree or PhD holder in PV, public health, epidemiology and drug safety and other relevant fields, Minimum 5 year – working experience in relevant fields

Other selection criteria:

·         Familiarity with Vietnamese Pharmacovigilacne System, capacity assessment and capacity development approach will be an asset

Application: Professional CV including an individual picture, Express of interest letter, Draft proposal of the assignment (The project assures to keep confidential all the application information including draft proposal)

Contact information

Applicant sends hard copy of application profile (by post or fax) to:

·         Address: Global Fund Project – Pharmacovigilance component – The National Drug information and Adverse drug reactions monitoring (DI&ADR center) – 13 -15 Le Thanh Tong, Ha Noi, Vietnam

·         Phone: +84 439335618, Fax: +84 439335642

And an electronic copy to pv.gf10@gmail.com

Contact person: Nguyen Phuong Thuy (phone: + 84 949919993) email: nguyenphuongthuy93@gmail.com