Terms of Reference for Pharmacovigilance Consultant
1.Background...
The ECOWAS PHC (ECOWAS
PHC) was
established on
September 10, 2010 to ensure that all medicines and health products
in the
national supply chain of ECOWAS are safe, effective and of good
quality. The ECOWAS PHC
plays key roles in monitoring the safety of medicines and health
products
through the Department of Pharmacovigilance & Clinical Trials.
Therefore, the
effective functioning of the PV/CT Department largely depends upon
the requisite
trainings and skills to carry out work operations.
Due to increased
availability and use of medicines
and health products for the management and control of diseases,
there is
the need to monitor adverse drug reactions (ADRs). In some
countries,
ADRs are ranked among the top leading causes of mortality despite
the
fact that most of them can be preventable. In addition, management
of
ADRs require substantial amount of resources which can be a burden
on
healthcare delivery system. As a result of the increase in
over-the-counter medicines, self-medication is on the rise and thus
posing higher risk for drug-drug interaction, over dosage and other
drug
related problems. There is need for vigilance at all healthcare
facilities; also at border posts on medicine importation due to
porous
borders and availability of counterfeit and substandard medicines in
the
market. It is thus, essential to implement a robust
Pharmacovigilance
system to monitor the safety of these medicines at all times and at
all
levels of the healthcare system.
*Objectives (General and Specific)
The consultancy is
intended to strengthen the
capacity of PV/CT staff to become efficient in monitoring the safety
of
all medicines and health products, and support the collection,
assessment (analysis), documentation and communication of reports on
ADR
surveillance in ECOWAS.
Specifics
Specifically, the
following areas will be covered by
the consultancy:
*
SWOT analysis of the
Pharmacovigilance system of ECOWAS PHC
* Review available Pharmacovigilance
documents to
conform to acceptable best practice
* Identify and draft PV development
plan
* Identification and develop template for
SOPs for all
PV process
* Provide hand-on training on causality
assessment of
adverse drug reactions for PV staff Scope of Work and
methoWansougy
During the
consultancy, the PV/CT Department is
expected to undergo system review and strengthening. This will occur
in
4 phases, but this advert is for Phase I only: Assessment of
National PV
System
* Phase 1:
Assessment of National PV System
Due to the COVID-19 Pandemic,
it is expected that the first phase of the consultancy will be
done
through virtual meetings. The consultant will conduct SWOT
(Strengths,
Weaknesses, Opportunities, and Threats) analysis virtually to
understand
the workings of ECOWAS PHC’s safety monitoring department.
Assessment of the
National PV
System will be undertaken using the WHO Global Benchmarking Tool
(GBT)
and the Indicator-Based Pharmacovigilance Assessment Tool
(IPAT)[1][2].
A pharmacovigilance system is defined as a system used by an
organization to fulfil its legal tasks and responsibilities in
relation
to pharmacovigilance and designed to monitor the safety of
authorized
medicinal products and detect any change to their risk-benefit
balance[3]. We will therefore assess the structure, processes,
and
outcomes of the National PV System.
Training needs of The ECOWAS PHC PV staff will also be assessed and
a
training
plan developed based on job description and responsibilities.
The assessment of National PV System
will also include a thorough
mapping of national and global stakeholders involved in PV
activities.
This mapping will enable leveraging of existing technical,
infrastructural, and financial resources and foster
collaboration
between PV actors to avoid duplication of efforts and create
more
impact.
*Deliverables
*
Outcome of National PV System assessment
* Strategy and plan to improve the
National PV System
including identifying PV training needs of ECOWAS PHC PV staff
*Duration
Duration of the consultancy
shall be ten (10) working days (to be stipulated in the
contract). The
current period of consultancy will cover phase 1 only.
*Payment
modalities
Payment modalities shall be
stipulated in the final contract.
*Candidate
profile
The Pharmacovigilance
Consultant should have a strong subject matter understanding of
PV and
safety operations processes (including causality assessment,
post market
surveillance, etc.) capabilities, regulations and systems. The
consultant should have project management skills and have proven
experience in working and strengthening National PV Systems.
*Application Process and contact details
Interested Candidates should
address applications to the following address:
Director of Human Resource
(HR)
ECOWAS PHC (ECOWAS PHC)
Rue 333 Gbegamey Cotonou, Littoral, C000, ECOWAS Republic,
W/A
+229 56861526 | +229 56861249
Send only to the following emails:
Email: info@ecowasphc.org
Note: Deadline for submission of
all applications: September 5, 2023.
1.Background...
The ECOWAS PHC (ECOWAS PHC) was established on September 10, 2010 to ensure that all medicines and health products in the national supply chain of ECOWAS are safe, effective and of good quality. The ECOWAS PHC plays key roles in monitoring the safety of medicines and health products through the Department of Pharmacovigilance & Clinical Trials. Therefore, the effective functioning of the PV/CT Department largely depends upon the requisite trainings and skills to carry out work operations.