USP
seeks a Pharmacovigilance expert for an anticipated 3-year project in DRC,
where USP will provide assistance towards strengthening the maturity level of
the National Pharmaceutical Regulatory Authority (ACOREP), strengthening
capacities of the National Quality Control Laboratory, and developing strategy
to strengthen local production of medicines and vaccines. The Pharmacovigilance
consultant will support USP by advancing the capacity of the pharmacovigilance
staff of ACOREP to perform key tasks necessary for attaining maturity level 3
on the GBT.
**This
opportunity is connected to a proposal. Any consultant engagement is contingent
upon contract award.**
Roles and Responsibilities
Potential tasks that the consultant/vendor will be
responsible for carrying out in collaboration with USP HQ and field experts and
ACOREP staff include:
· Identify key gaps within the pharmacovigilance system using
existing GBT assessment reports and the institutional development plan or
similar documents that may be available
· Review and update the regulatory framework, regulations,
ministerial order, guidelines and policies as relevant for effective
implementation of pharmacovigilance activities
· In collaboration with
ACOREP staff and guided by the institutional development plan, lead the review,
updating/drafting, validation, and finalization of procedures, SOPs, and tools
to strengthen safety monitoring systems. This includes integrating risk-based
approaches in alignment with international best practices and standards, with
the goal of achieving GBT maturity level 3.
· Support the development and implementation of a two-year
training plan focused on competency-based training and capacity building for
pharmacovigilance staff including review of safety reports, analysis and
management of adverse events reports, signal detection and management, PV
inspections and audits, risk communication and collaboration with stakeholders.
· Actively mentor and undertake knowledge transfer on core
regulatory PV competencies to staff of ACOREP.
· Support ACOREP staff to implement regulatory reliance
practices such as joint safety reviews and report assessment and encourage
sharing of information with key national, regional and international
stakeholders
· Undertake any other activity agreed by the project team and
ACOREP as necessary for achieving maturity level 3 for the PV system on the
GBT.
Qualifications
· A university degree (minimum 5 years of higher education) in
pharmacy, pharmaceutical sciences, medicine, chemistry, biochemistry, biology,
public health or related fields.
· At least 7 years of demonstrated international experience in
strengthening regulatory systems - particularly in national regulatory systems,
drug and other products safety monitoring, clinical trials or other key
regulatory functions.
· Demonstrated expertise in the field of pharmacovigilance
(PV) with a track record in developing PV-related documents, signal detection
and management, risk assessment, safety report generation and or review,
causality assessment and capacity building for the implementation of best
practices in pharmacovigilance.
· Prior experience working with a national regulatory
authority or the pharmaceutical industry on pharmacovigilance is highly
desirable
· Located in Africa Region.
· Fluent in English Required. Fluent in French preferred.
Preferred Qualifications
· Strong understanding of global PV regulations (ICH, EU GVP, WHO).
· Excellent analytical and data interpretation skills.
· Effective communication and ability to train and write reports in French
and English languages.
· Familiarity with PV software and databases (e.g., VigiFlow, VigiBase,
Med Safety App, ODK Connect).
· Ability to work collaboratively with diverse stakeholders.
· Experience working with or on donor funded projects.
Application
Procedure
Please send your CV, Cover Letter, 3
References, and hourly rate (in USD) to GPH_Procurement@USP.org, by the
closing date of December 19, 2025. When submitting your applications,
please write “Pharmacovigilance Expert (Africa Region)” in the email Subject
Line of your email.
The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates
with the world's top experts in health and science to develop quality resources
and standards for medicines, dietary supplements, and food ingredients. Through
our resources, standards, advocacy and education, USP helps increase the
availability of quality medicines, supplements and foods for billions of people
worldwide. USP’s Global Health programs have reached more than 90 countries across Africa, Asia, and North and
South America to strengthen global supply chains and pharmaceutical ecosystems
that enable a resilient supply of quality medical products.
