USP
seeks a Market Surveillance and Control 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 Market
Surveillance and Control consultant will support USP by strengthen the market surveillance and
control function of ACOREP including developing and implementing relevant
procedures to ensure attainment of WHO GBT Maturity level 3 for the function.
**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 include:
o Review and update
national guidelines, SOPs, and policies for market surveillance and control as
necessary.
o Align processes and
procedures with WHO guidelines and international best practices.
o Provide expert input
on quality monitoring strategies for medicines, vaccines, and medical devices.
o Support the design and
implementation of risk-based post-market surveillance systems including use of
the MedRS tool for protocol development, sampling, testing, and reporting.
o Assist in analyzing
surveillance data and generating periodic reports.
o Support integration
and utilization of reports of adverse events and quality defects in regulatory
decision making.
o Train NRA staff on
risk-based surveillance, investigation of SF products, and enforcement actions.
o Develop training
materials and conduct workshops.
o Facilitate
collaboration with relevant stakeholders including customs, law enforcement,
health programs, regional initiatives, manufacturers, distributors, and
healthcare providers.
o Support communication
strategies for public alerts and advisories.
Qualifications and experience
· Have a university degree (minimum 5 years of higher
education) in pharmacy, pharmaceutical sciences, regulatory sciences, chemistry,
biochemistry, biology, public health or related field.
· Minimum of 7 years’ experience working in
regulatory affairs, quality assurance, or pharmacovigilance.
· Proven experience in post market surveillance or
quality control of medical products, preferably working within an NRA in an
LMIC
· At least 5 years of international experience in
strengthening regulatory systems - particularly in national regulatory systems,
quality assurance, pharmacovigilance or similar regulatory functions.
· Familiarity with WHO guidelines, WHO GBT
requirements for market surveillance and control, ISO standards and risk-based
approaches
· Resides within the Africa Region.
Required Skills
· Strong analytical and problem-solving skills.
· Knowledge of laboratory testing protocols and
quality management systems.
· Excellent communication, report writing, and
stakeholder engagement abilities.
· Proficiency in data management tools and
reporting systems.
· Familiarity with the MedRS tool is a plus
· Fluency in English Required. Fluency in French preferred.
· Ability to travel and work in-country as needed.
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 “Market Surveillance 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.
