Jun 20, 2017

Cambodia: International Technical Assistance

NGO/UN Job Vacancy



Organization: UNOPS
Country: Cambodia
Closing date: 02 Jul 2017

1. Purpose of the Consultancy

The purpose of the consultancy is to develop Guidelines on Pharmacovigilance for Public Health Programs (PHP PV) and revise the existing Guidelines for Adverse Drug reactions (ADR) Monitoring and Related Matters (published in 2012) of the Ministry of Health, Kingdom of Cambodia. After the development and revision of the two guidelines, the consultant will provide a 5-day hands- on training workshop to PV focal points including public health programmes. The detailed terms of reference are as stated below.

In collaboration with the Pharmacovigilance Centre, Department of Drugs and Food and National Programmes, the consultant will undertake following tasks:

1. Define minimum requirements for PHP PV activities based on a review and assessment of the existing pharmacovigilance system, the revised Guideline on Adverse Drug Reactions (ADR) Monitoring and Related Matters and international guidelines.

2. Facilitate a national consultation to review the draft guidelines involving pharmacovigilance and national programmes focal points

3. Revise the existing Guideline on Adverse Drug Reactions (ADR) Monitoring and Related Matters, 2012

4. Develop the Guideline for Pharmacovigilance for Public Health Programmes (malaria, TB and HIV/AIDS) in line with revised guidelines. The draft guidelines should cover: coordination; database, causality (relationship) assessment and data analysis; special situations; decision-making; and international linkage.

5. Provide practical guide and recommendations on effective implementation of the guidelines

6. conduct the 5-day hands-on training on the revised guidelines for ADR Monitoring and Related Matters and the newly developed guidelines on Pharmacovigilance for Public Health Programmes.

7. Provide a technical report along with the draft guidelines and practical guide for their implementation

2. Background

A National Pharmacovigilance (PV) system was established in Cambodia in July 2008 at Department of Drugs and Food (DDF), Ministry of Health to improve medicine safety monitoring in both the public and private sectors, including formation of the Cambodian PV Center. This significant milestone represented an important first step to establishing a comprehensive PV system within the Cambodia health system to systematically monitor, record, and share adverse drug events (ADEs) and adverse drug reactions (ADRs) occurring in the country. A Pharmacovigilance Safety Expert Advisory Committee was established in January 2010, with the purpose of guiding operations of the PV system in Cambodia. Cambodia joined the World Health Organization (WHO) Programme for International Drug Monitoring as an associate member in 2008 and in 2012 Cambodia became official members of the program after achieving minimum requirements for full membership.

National PV guideline, Guidelines for Reporting ADR and Related Matters, were introduced in August 2012. It contains specific guidelines on signal detection, risk assessment, decision making, and communication. Further, MOH administrative orders stipulate mandatory reporting by product marketing authorization holders (MAH), such as pharmaceutical companies, to submit suspected ADR reports to the DDF. MAH are not required in legal provisions or policy statements to conduct post-marketing surveillance, a critical role for industry for products identified as high risk or with unknown safety profiles.

For Public Health Programmes, there are guidelines in place for active pharmacovigilance monitoring with a special focus on artemisinin combination therapy (ACTs) in fixed dose combination (FDC) supplied by Affordable Medicines Facility-malaria (AMFm).

http://ift.tt/2sw7jmP

The Assessment of the Pharmacovigilance System and its Performance: Safety of Medicinal Products in Cambodia (February 2013, USAID/SIAPS) found that PHPs in Cambodia have particularly weak systems and structures in place to address pharmacovigilance systems and it encourages the Cambodia MOH to support such programs in taking initial steps to introduce PV practices. The assessment also recommends that Cambodia considers formalizing the current role of PV focal point persons located within public health departments (PHDs) and operational districts (OD) through the establishment of regional PV Centers within key health facilities, supported with MOH funds to raise awareness and build capacity of health facilities, pharmacies, industry, and other PV stakeholders at the district and regional level to participate in the national PV program, modeling systems introduced elsewhere in Asia including Nepal.

In November 2014, a WHO Consultant provided technical support on development of standard operating procedures, and a total of 9 SOPs (3 reviewed + 6 new drafts) were developed during this consultancy: (1) SOP for receiving & processing ADR reports, (2). SOP for receiving & answering Drug Information requests; (3) SOP for ADR causality Assessment & giving of feedback; (4) SOP for publishing PV Bulletin; (5) SOP for organizing expert Committee meetings; (6) SOP for organizing trainings & workshops; (7) SOP for Maintaining PV website; (8) SOP for managing ICSR data in VigiFlow; and (9) SOP for HCPs – Filling and sending an ADR report.

3. Planned timelines

Please see the planned timeline in ToR, stored in https://goo.gl/KKSw7o.

4. Work to be performed

  • Review and assessment of existing guidelines and procedures
  • Interview and consultations with staff and responsible persons from Pharmacovigilance Centre, Department of Drugs and Food, and National Programmes as consulted
  • Define requirements for PHP PV
  • Develop guidelines for PHP PV
  • Facilitation of a consultative meeting

5. Payment Schedule:

  1. 20% payment will be done upon successful completion of (deliverable #1 & 2 of ToR)
  2. 40% payment will be done upon successful completion of (deliverable #3 & 4)
  3. 30% payment will be done upon successful completion (deliverable #5 & 6)
  4. 10% payment will be done upon acceptance of the final product

6. Technical Supervision

The selected Consultant will work on the supervision of:

Responsible Officer:

SEA THOL

Manager:

HENG BUNKIET

7. Specific requirements

Qualifications required:

Strong regulatory experience and knowledge on how to implement Pharmacovigilance system in resource-limited settings

Experience/Skills / Technical skills and knowledge:

· At least 10 year of experiences working in the areas of post-marketing surveillance and pharmacovigilance

· The Consultant needs to be committed to maintain utmost confidentiality at all times, and any information obtained during the review process is not to be disseminated without prior approval from MOH.

  • Language requirements:

English (Read - Write - Speak / Expert)

Competencies

· Communicating in a credible and effective way

· Producing results (Produces and delivers quality results: action oriented and committed to achieving the deliverables)

· Respecting and promoting individual and cultural differences

8. Place of assignment

Pharmacovigilance Centre, Department of Drug and Food, Ministry of Health, Phnom Penh


How to apply:

Detailed ToR and Financial Proposal Form is available at https://goo.gl/KKSw7o.

Applications and financial proposal should be submitted via email to assistance.ddf@gmail.com. Only shortlisted candidates will be contacted.