CONSULTANCY OPPORTUNITY: PHARMACEUTICAL EXPERT
Management Sciences for Health (MSH), a global health nonprofit organization, uses proven approaches developed over 40 years to help leaders, health managers, and communities in developing nations build stronger health systems for greater health impact.
We work to save lives by closing the gap between knowledge and action in public health.
For more information please visit our website www.msh.org.
SCOPE OF WORK FOR A CONSULTANT TO SUPPORT COMPLIANCE OF LOCAL PHARMACEUTICAL MANUFACTURERS TO GOOD REGULATORY PRACTICES
Funded by the US Agency for International Development (USAID), the Medicines Technologies and Pharmaceutical Services (MTaPS) Program provides pharmaceutical system strengthening assistance for sustaining improvements in health system performance.
The goal of the global, USAID MTaPS Program is to enable low- and middle-income countries (LMICs) to strengthen their pharmaceutical systems to ensure sustainable access to and appropriate use of safe, effective, quality assured, and affordable essential medicines and pharmaceutical services.
To achieve this goal, USAID MTaPS program has objectives related to improving governance, human and institutional resource capacity, and information for decision making, financing, and services.
To achieve its objectives, USAID MTaPS Program has adapted a country led and regional led approach to ensure sustainable resilient pharmaceutical systems.
USAID MTaPs is therefore applying the pharmaceutical systems strengthening approach to the Regional Economic Community (RECs) blocks of East African Community (EAC) and Intergovernmental Authority on Development (IGAD) under the Medicines Regulatory Harmonization (MRH) initiatives to achieve results in the following focal areas:
- Pharmacovigilance and patient safety
- Good regulatory practices for medicines and other medical products
The aim of this approach is to enable IGAD/EAC to strengthen the pharmaceutical system to ensure sustainable access to and appropriate use of safe, effective, quality-assured, and affordable essential medicines and medicine-related pharmaceutical services.
The USAID MTaPS program has developed specific objectives around the focal areas to address identified outcomes. As such one of the objectives; Strengthen institutional and human resource capacity to manage pharmaceutical systems’ with a sub-objective to Strengthen medicines regulatory capacity in the IGAD/EAC region’ aims to support local manufacturers in the IGAD/EAC regions to better comply with regional and national pharmaceutical regulatory standards and requirements”
USAID MTaPS therefore seeks to recruit a Pharmaceutical expert who shall carry out an assessment of the IGAD/EAC local pharmaceutical industry to gauge their capacities to adhere to good regulatory practices to ensure sustained availability of critical essential medicines /commodities in line with international standards.
Support local pharmaceutical manufacturers in the IGAD/EAC regions to better comply with regional and national pharmaceutical regulatory standards and requirements to ensure safe, quality assured medicines and other medical products and increased investments within the pharmaceutical sector in the two regions
Undertake an assessment of the local pharmaceutical industry to examine their capacities to adhere to good regulatory practices to ensure sustained availability of critical essential medicines in line with international standards.
D. SCOPE OF WORK:
The consultant will work with the focal MTaPS staff to develop a strategy and coordinate implementation of common set of tools to assess the capacities of local pharmaceutical manufacturers within the EAC/IGAD member states to adhere to good regulatory practices as specified by WHO, the region and partners/member states.
Specific tasks for the consultant include the following:
1. Develop a strategy to rapidly assess capacities of local pharmaceutical manufacturers in the EAC/IGAD region to adhere to good regulatory practices that ensure quality, safety and efficacy of products including Pharmacovigilance regulatory capacities.
2. Undertake an assessment of the pharmaceutical industry and identify strengths and barriers to adoption and uptake of pharmacovigilance activities by local manufacturers in the region and propose strategies or recommendations to address identified barriers
3. Develop a strategy that brings together and sustains engagement of local pharmaceutical manufacturers in the EAC/IGAD region in ensuring regulatory compliance to good regulatory practices
4. Identify and develop a strategy that brings together the various stakeholders in the pharmaceutical industry including national medicines regulatory Authorities to enhance or promote regulatory compliance and build capacities within the region.
5. Develop and design collaborative improvement plans with stakeholders for the development, deployment and implementation of appropriate tools necessary to improve compliance to pharmaceutical regulatory requirements
including those for pharmacovigilance.
E. EXPECTED DELIVERABLES
1. Inception report for the comprehensive assignment showing the strategy to be applied to complete the task
2. Assessment tools or questionnaire(s) and implementation plan
3. Assessment report on the regulatory compliance practices local pharmaceutical manufacturers in EAC/IGAD region.
4. Stakeholder engagement and management plan
5. Stakeholder improvement plans for enhancing pharmaceutical regulatory compliance.
6. Rapid sensitization and communication package
F. DURATION OF THE ASSIGNMENT
The assignment is for a fixed period of 20 working days between May and June 2020.
The consultancy fee will be commensurate with the qualification and experience of the successful candidate.
Payment schedule will be based on the milestones shown above on the deliverables.
MSH Offices, Nairobi. Due to travel restrictions, the consultant will be expected to explore ways of obtaining information from the region through working with specific focal persons to get required information.
I. EFFECTIVE DATE
Work is expected to be initiated on or about 25th May 2020.
J. QUALIFICATIONS AND EXPERIENCE
i. Minimum of a degree in Pharmacy from a recognized institution.
ii. At least 15 years working experience with broad understanding on various areas of pharmaceutical practice including policy, regulatory, manufacturing, distribution and retail practices
iii. Demonstrated experience working at senior strategic levels to advance pharmaceutical policy and practices
iv. Demonstrated good program design skills, including capacity to prepare logical, coherent and consistent documents. Ability to work in a multi-disciplinary team, including coordinating technical input into a framework.
v. Ability to work rapidly, both in person and remotely, with team members in various locations.
vi. Ability to work with minimal supervision.
vii. High level written and oral communications skills in English and Kiswahili.
viii. Must be result oriented team player with excellent interpersonal skills, including enthusiasm, tact, diplomacy and high level of integrity.
ix. Past working experience with the local manufacturing sector in EAC and IGAD is an added advantage.
For further detail and to apply, please visit the Employment Opportunities section of our website at www.jobs-msh.icims.com by May 13, 2020.
If you cannot apply online, or have difficulty doing so, please email an explanation of your problem to iRecruiterproblem@msh.org.
Only shortlisted candidates will be contacted.