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Senior Post Marketing Surveillance Specialist

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About National Medicine and Healthcare Products Regulatory Authority

SEHAT is jointly financed by the World Bank and ARTF. It is financing the implementation of the BPHS and EPHS through contracting out and contracting in arrangements both in rural and urban areas in provinces the project is also strengthening the national health system and MOPH’s capacity at central and provincial levels, so it can effectively perform its stewardship functions in the sector.
Strengthening pharmaceuticals service and regulation are the top priorities for the MoPH. Despite the role that to regulate the pharmaceutical sector, there is significant fragmentation in the system: inspection and regulatory system needed to control the sector are scattered across various MoPH departments.

National Medicine and Healthcare Products Regulatory Authority (NMHRA) functions to regulate medicine and Healthcare Products in Afghanistan.
NMHRA is aimed to ensure availability of effective and safe medicine and healthcare products with high quality and fair prices. It works to manage and control production, import, delivery and distribution of medicine and healthcare products to ensure efficacy, safety and quality. The authority develops and implements effective standards for improving safety, effectiveness, quality and ease of access to medicine and healthcare products throughout the country.
Core functions of NMHRA includes developing and enforcing medicine and healthcare products related rules, regulations and policies, licensing businesses and professionals, registration and control of medicine and Healthcare Products including Narcotics and Psychotropic drugs, pre and post market quality control and surveillance, regulation and control of advertisements and publicity, determination and control of prices, and clinical trials regulation and control.

Job Summary

The scope of post marketing surveillance specialist is supporting the post marketing surveillance functions for detection, analysis of any possible signals on quality defects and safety alerts to safeguard the public health.
Deliverables:
• Guidelines, SOPs for implementation of post market surveillance developed
• Post market surveillance system established
• Database and electronic records in accordance with legal and good record keeping practice created
• The tools and guideline for post market surveillance piloted and revised based on lessons learnt from pilot

Job Details

Date Posted: 05 Aug 2017 Reference: NMHRA-HR-2017/05
Closing Date: 14 Aug 2017 Work Type: Full Time
Number of Vacancies: 1 Gender: Any
Functional Area: Health/Medical Open Ended: NO
Nationality: Afghan Salary Range: As per NTA Salary Scale Policy
Contract Type: Service Contract Years of Experience: 5 Year(s)
Contract Duration: 0 Year(s) & 9 Month(s) Extension Possibility: Yes
Probation Period: 3 Months

Duties and Responsibilities

1. Support developing a phase-wise national plan for Post Marketing Surveillance (PMS) Pharmacovigilance (PV)
2. Facilitate train on the of post marketing surveillance methodologies
3. Facilitate developing of required guidelines SOPs and Forms for implementation of surveillance.
4. Help on establishing good work environment
5. Support implementation of pilot stage of Post market surveillance.
6. Technical support for establishment of archiving and retrieval system
7. Technical support for establishment of well-equipped Library system
8. Conduct daily activities of the Complaints to ensure appropriate review of product complaints and product analysis results and submission of Medical Device Reports (MDRs).
9. Receive incoming complaint reports on real and/or perceived issues via phone, written or electronic reports.
10. Create database and electronic records in accordance with legal and good record keeping practices.
11. Ensure complaint investigations are adequate, accurate and timely.
12. Coordinate the return of material and/or product for analysis.
13. Perform data analysis to alert management to trends revealed by complaints and reported events.
14. Perform peer reviews for complaint closure activities
15. Support partnership with national and international agencies for exchange of information/knowledge and experience
16. Implement advocacy programs for collection of safety/quality reports from public and private sectors.
17. Coordinate with other pharmaceutical programs in order to prevent from any overlaps duplication or gaps between the related activities.
18. Provide regular or ad hoc plan or report in coordination with post marketing surveillance advisor as per request GDPA/MoPH or Word Bank.
19. Perform any other task as per required by pharmaceutical steering committee

Travels to Provinces

Require Travels to Provinces

Skills

• Good communication skills.
• Good command of English, local languages and computer skills.

Qualifications

• University degree in Pharmacy, medicine or public health. Candidates having master degree is preferred.
• Five year post graduate experience in health management with government or Non-Governmental Organization or UN or donor community including at least two year working experience the field of pharmacy sector.

Job Location

Afghanistan - Kabul

Education:

Bachelors Degree, Health/Medical

Submission Guideline

Please send your CV with cover letter to bellow email address and mention Job title and vacancy number in the subject line.
Hard copy of CV could be submitted to National Medicine and healthcare Products Regulatory Authority office at Street #6, Shirpoor, Kabul, Afghanistan.
Note: No resume will be considered if received after the closing date.
Only shortlisted candidates will be called for written test and interview.

Submission Email

hr.nmhra@gmail.com

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