Jobs in Dar es Salaam Tanzania Msh Jobs in Dar es Salaam Consultant – Regulatory Systems Strengthening (Pharmacovigilance) Jobs in Dar es Salaam at Msh Consultant – Regulatory Systems Strengthening (Pharmacovigilance) Employment opportunities Msh




# Job Description


Introduction and Background

Funded by the U.S. Agency for International Development USAID, the
Medicines,

Technologies, and Pharmaceutical Services MTaPS program implemented by
Management Sciences for Health provides pharmaceutical system strengthening
assistance for sustained improvements in health system performance and to
advance USAID’s goals of preventing child and maternal deaths, controlling the
HIV/AIDS epidemic, and combating infectious disease threats, as well as
expanding essential health coverage.

The goal of the global, five-year 2018–2023 program is to enable low- and
middle-income countries to strengthen their pharmaceutical systems to ensure
sustainable access to and appropriate use of safe, effective, quality-assured,
and affordable essential medicines and medicine-related pharmaceutical
services. To achieve this goal, the MTAPS program has the following
objectives

• pharmaceutical sector governance strengthened

• institutional and human resource capacity for pharmaceutical management and
services increased, including regulation of medical products

• availability and use of pharmaceutical information for decision making
increased and global learning agenda advanced

• pharmaceutical sector financing, including resource allocation and use,
optimized

• pharmaceutical services, including product availability and patient-
centered care to achieve desired health outcomes, improved

The goal of MTaPS in Tanzania is to strengthen the country’s pharmaceutical
system to ensure sustainable access to and appropriate use of safe, effective,
quality-assured, and affordable essential medicines, including ARVs, health
technologies, and related pharmaceutical services. A stronger pharmaceutical
system in Tanzania will enable achievement of global goals, including
controlling the HIV/AIDS and TB epidemics, preventing child and maternal
deaths,

combating other infectious disease threats, and expanding access to essential
medical products in the journey toward achieving universal health coverage in
the country.

The Tanzania Medicines and Medical Devices Agency TMDA is the national
regulatory authority NRA in Tanzania. It is an executive agency under the
MOH responsible for regulating the quality, safety, and effectiveness of
medicines, medical devices, and diagnostics. Its core functions are prescribed
in Section 5 of the Tanzania Medicines and Medical Devices Act, Cap 219, i.e.,
the regulation of all matters relating to quality, safety, and efficacy of
human and veterinary medicines, herbal medicines, medical devices, and
diagnostics; the regulation of importation, manufacturing, labeling, marking
or identification, storage, promotion, sale, and distribution of same; and the
monitoring and analysis of existing and new adverse events, interactions, and
information about PV of products; and acting upon said analysis.

Regulatory systems play a key role in ensuring the quality, safety, and
efficacy of medical products. The TMDA has attained WHO maturity level 3 ML
3 status for setting up a stable, well-functioning, and integrated
medicine/vaccine regulatory system, as benchmarked against the World Health
Organization WHO Global Benchmarking Tool GBT in 2018. It has also
established mobile and patient reporting systems for safety monitoring of
medicines.

The Medical Stores Department MSD is an autonomous department under the MOH
responsible for developing, maintaining, and managing an efficient and cost-
effective system of procurement, storage, and distribution of approved
medicines and medical supplies required for use by public health services.

MTaPS is therefore seeking a consultant to provide technical assistance to
support medicines registration, medical products importation procedures and
pharmacovigilance to achieve the goal of strengthening regulatory systems in
the Republic of Tanzania.

Su pervision and reporting responsibility The consultant will be
supervised by, and report to the Principal Technical Advisor-Pharmacovigilance
PV Lead. The consultant will liaise with the Country Project Director for
Tanzania; the Principal Technical Advisor-Pharmaceutical Regulatory Systems
PTA-PRS, MTaPS headquarters and regional technical staff, and work in
collaboration with the national regulatory authority and relevant government
departments.

A Description of Services to be provided

Based on the background information provided by MTaPS, the consultant is
expected to provide

technical assistance by undertaking interventions in medicines registration,
medical products importation procedures and pharmacovigilance that will
strengthen regulatory systems, contributing to access to quality assured
medical products.

Specifically, the consultant will undertake the following activities

1 Activity 1.1.1 Conduct a process improvement mapping for registration and
importation of antiretroviral medicines ARVs, including dolutegravir DTG,
for the public sector LOE

20 Days

a. Develop an implementation plan for this activity with clear tasks and
timelines for reaching process improvement milestones

b. Liaise with the MTaPS Tanzania Country office to initiate meetings with the
National Regulatory Authority, TMDA, and MSD, and plan for collection of
information and implementation of the activity

c. Develop a checklist/questionnaire for data collection on the sequence of
activities to register and import ARVs, including DTG, for public sector
distribution and use

d. Administer the questionnaire to relevant entities including MSD, TMDA

e. Prepare draft report on the findings of the process mapping including
considerations for process improvements

f. Facilitate a one-day virtual workshop to validate the findings

g. Finalize the report on process mapping improvement for registration and
importation of ARVs, including DTG, for the public sector.

2 Activity 1.1.2 Sustain the capacity of TMDA to assess quality, safety, and
efficacy of ARVs

LOE 15 days

a. Develop an implementation plan for this activity with clear tasks and
timelines for reaching the capacity milestones and share it with the PTA-PRS

b. Liaise with MTaPS Tanzania Country office to initiate meetings with the
National Regulatory Authority, TMDA, and plan for delivery of virtual/in-
person course to conduct capacity building on comprehensive assessment of
quality, safety, and efficacy of ARV applications for registration. The
capacity building should impart knowledge and transfer skills to TMDA
assessors in basic dossier assessment of ARV product dossiers for the new
medicine evaluators new staff, interns, and externals; and training to
current medicine evaluators on specialized areas, such as assessing
bioequivalence studies and active pharmaceutical ingredients, focusing on ARVs

c. Liaise with the appropriate academic institution for collaboration while
implementing the capacity building workshop

d. Prepare materials for delivery of a 5-day capacity building course on
evaluation and registration of medicines, covering training of new assessors
and refresher training for existent assessors

e. Organize and facilitate conduct of an in-person capacity building workshop
on assessment of product dossiers for medicines

f. Prepare Report on capacity building workshop on product registration for
medicines for regulators in Tanzania

g. Organize and facilitate conduct of a product dossier evaluation retreat for
5 days for the assessors to apply the knowledge and gain hands-on experience
in evaluating products, specifically medicines used to manage HIV/AIDS

h. Prepare Report on product dossier evaluation retreat and number of product
files for managing ARVs evaluated.

3 Activity 2.1.1 Strengthen existing passive medicine safety surveillance
system for pediatric medicines used in national HIV program LOE 20 days

a. In collaboration with relevant TMDA and MTaPS staff, plan and set up a
pediatric sub-committee as part of the national safety advisory committee to
evaluate adverse drug reaction ADR reports on pediatric DTG and other
pediatric ARVs in the country

i. Undertake review of the terms of reference of current national safety
advisory committee and revise it for setting up the pediatric sub-committee as
necessary

ii. Establish a governance structure for the pediatric sub-committee with
clear deliverables for enhancing the safety of pediatric DTG and ARVs in
general

iii. Support inauguration of the committee members and at least one meeting of
the committee.

b. In collaboration with WHO, relevant industry experts, and MTaPS staff,
plan, execute and monitor capacity building of TMDA staff on evaluating
manufacturers’ risk management plans RMPs and periodic safety update reports
PSURs for pediatric drug formulations as part of a system-wide sustainable
capacity-building effort

i. Review or develop training materials

ii. Undertake training of staff including hands-on practice iii. Generate a
report of the training.

c. Work with TMDA and relevant stakeholders including but not limited to
public health programs, hospitals, and reporters to strengthen the existing
system for providing constructive feedback to stakeholders that report ADRs.
This will entail reviewing the current feedback mechanism and identifying
implementation gaps, including disincentives for reporting

i. Review current feedback mechanism available at TMDA and identify
implementation gaps

ii. Develop a revised stakeholder feedback framework and mechanism

d. Develop a proposal for a follow-on activity that identifies and tests
different strategies for improving reporting with a view to finding the most
appropriate and context relevant strategy to improve ADR reporting in
Tanzania.

Total LOE 55 days

B Deliverables/Milestones

1 Implementation plan for Activity 1.1.1 with clear tasks and timelines for
reaching the

process improvement milestones

2 Draft report on the findings of the process mapping including
considerations for process improvements

3 Report on process improvement mapping for registration and importation of
ARVs, including DTG, for the public sector

4 Implementation plan for Activity 1.1.2 with clear tasks and timelines for
reaching the capacity milestones

5 Materials for delivery of a virtual 5-day capacity building course on
evaluation and registration of medicines

6 Report on virtual capacity building on medicines registration for
regulators in Tanzania

7 Report on product dossier evaluation retreat and number of product files
for managing

ARVs evaluated

8 Terms of reference for a pediatric advisory sub-committee, including
governance structure

9 Results of DTG and other pediatric ARVs ADR review

10 Report of training for TMDA staff on review of RMPs and PSURs for
pediatric ARVs

11 Proposal for follow-on activity on strategies to improve reporting of
ADRs.

C Delivery Schedule/Milestones

Activity 1.1.1 Conduct a process improvement mapping for registration and
importation of ARVs, including

D TG, for the public sector

1 Deliverable Activity Implementation plan with clear tasks and

timelines for reaching process improvement milestones 15 June 2021

2 Draft report on the findings of the process mapping including

considerations for process improvement 30 June 2021

3 Final Report on process improvement mapping for registration

and importation of ARVs, including DTG, for the public sector 25 July 2021

Activity 1.1.2 Sustain the capacity of TMDA to assess quality, safety, and
efficacy of ARVs

4 Activity implementation plan with clear tasks and timelines for reaching
capacity milestones 15 June 2021

5 Materials for delivery of a virtual 5-day capacity building course on
evaluation and registration of medicines 30 June 2021

6 Report on capacity building on medicines registration for regulators in
Tanzania 31 July 2021

7 Report on product dossier evaluation retreat and number of

product files for managing ARVs evaluated 31 August 2021

Activity 2.1.1 Strengthen existing passive medicine safety surveillance
system for pediatric medicines used in

national HIV program

8 Terms of reference for a pediatric advisory sub-committee, including
governance structure 30 June 2021

9 Results of DTG and other pediatric ARVs ADR review 20 September

2021

10 Report of training for TMDA staff on review of RMPs and

PSURs for pediatric ARVs 31 August 2021

11 Proposal for follow-on activity on strategies to improve

reporting of ADRs 31 July 2021

D Authorized Travel if applicable

MSH hereby authorizes Consultant to travel in connection with providing the
Services in accordance with the SOW as described below

Within Tanzania



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Closing Date 31st May, 2021.



Jobs in Dar es Salaam Tanzania Msh Jobs in Dar es Salaam Consultant – Regulatory Systems Strengthening (Pharmacovigilance) Jobs in Dar es Salaam at Msh Consultant – Regulatory Systems Strengthening (Pharmacovigilance) Employment opportunities Msh


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