Local Consultant for Pharmaceutical Registration and Importation
JOB DESCRIPTION
TITLE: Local Consultant for Pharmaceutical Registration and Importation
PROJECT: Global Health Supply Chain–Procurement and Supply Management in Vietnam
Project Overview: The purpose of the Global Health Supply Chain Program – Procurement and Supply Management (GHSC-PSM) project is to ensure uninterrupted supplies of health commodities in support of USG-funded public health initiatives around the world. The project provides direct procurement and supply chain management support to the President’s Emergency Plan for AIDS Relief (PEPFAR), the President’s Malaria Initiative (PMI), and Population and Reproductive Health. In supporting USG-funded global health activities, GHSC-PSM will develop and manage a wide array of services for health commodity procurement and supply chain system strengthening in encompassing different elements of a comprehensive supply chain.
At the country level, GHSC-PSM supports country strategies and priorities that fall under the following three project objectives:
- Global Commodity Procurement and Logistics
- Systems Strengthening Technical Assistance
- Global Collaboration to Improve Long-Term Availability of Health Commodities.
Background and Justification:
GHSC-PSM in Vietnam is supporting the Ministry of Health with the implementation of COP18 PEPFAR directives aimed at greater efficiencies and effectiveness in HIV/AIDS program activities, including the adoption of Tenofovir disoproxil fumarate-Lamivudine-Dolutegravir (TLD) as the preferred first-line regimen for HIV/AIDS treatment in the country. While the Government of Vietnam has included TLD in the National HIV/AIDS Treatment Guidelines since December 2017 (Ministry of Health decision 5418/QD-BYT dated 1/12/2017) as the alternate first-line regimen, the TLD transition in Vietnam has been delayed as TLD is not yet available in country. Domestic manufacturers do not produce TLD and it cannot be imported since no manufacturer has been granted Marketing Authorization (MA) for TLD in Vietnam.
The last weekend of March 2019, stake holder meeting between OGAC, PEPFAR and Vietnam Administration for HIV/AIDS Control (VAAC) , a goal was set for October 1, 2019 for processing the registration and importation of TLD to Vietnam and to begin use. For TLD to be rolled out within this timeline, the MA needs to be granted by August 2019. However, DTG is a new and non- registered/active ingredient in Vietnam, which makes obtaining the MA for TLD a challenge. Therefore GHSC-PSM requires a local consultant to advise on pharmaceutical registration and importation, specifically in regards to TLD registration and importation.
Purpose and Scope of Work:
The Local Consultant for Pharmaceutical Registration and Importation will work closely with VAAC, the Drug Administration of Vietnam (DAV)/Ministry of Health, GHSC-PSM technical staff and its local contractor, Central Pharmaceutical Company CPC1.JSC, to:
- Advise on regulations and procedures to register and import TLD and other medicine (when required) into the country successfully;
- Work closely with GHSC-PSM technical staff, local contractors, and related stakeholders in consolidating and reviewing the documents for TLD MA or import permit;
- Work actively with the Drug Administration of Vietnam (DAV)/Ministry of Health to follow-up and facilitate obtaining a TLD MA or import permit;
- Consult on other issues related to pharmaceutical registration or importation as requested.
Qualifications:
- A bachelor’s degree in Pharmacy or Medicine is required;
- A minimum of 5 years’ experience in Drug registration/importation permit
- Working experience with Drug Administration - Ministry of Health and international funded projects are preferred.
- Excellent interpersonal and communications skills;
- Fluency in Vietnamese and advanced English are required.
Timeframe Details:
This assignment is expected to take place in Hanoi, Vietnam from June 2019 to September 2019.
Estimated Level of Effort (LOE):
Up to a maximum of 320 billable hours (40 days) incurred within the timeframe stipulated above, and no more than 8 of which may be billed on any given day. Up to a maximum of 15 working days per month. Additionally, the consultant may work a maximum of five days per work week, unless approval by USAID is provided in writing in advance.
Location of Assignment:
This assignment is expected to take place in Hanoi, Vietnam.
Supervision:
The Local Consultant on Pharmaceutical Registration and Importation will report to the GHSC-PSM Technical Director in Hanoi, Vietnam.
Application Instructions:
Send electronic submissions to [email protected] by 10am, 9th Jun 2019 with only "Local Consultant for Pharmaceutical Registration and Importation" in the subject line. Only finalists will be contacted.
Chemonics is an Equal Opportunity/Affirmative Action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, or protected veteran status, genetic information, age, membership in an employee organization, or other non-merit factors.