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Ref.
2026/PTA/15928

Job offer type
Experts

Type of contract
Service contract

Deadline date
2026/08/15 23:59

Duration of the assignment
Beaded expertise

Contract
Freelancer

Duration
1 an renouvelable

Mission description

Purpose and principle of mobilisation

To complement the project’s core pharmaceutical expertise (the Lead Pharmaceutical Expert and the communication and awareness specialist, each recruited under separate terms of reference), MEDISAFE 2 mobilises a pool of specialised international consultants. This document describes the seven profiles sought. It serves as a call for expressions of interest: candidates apply individually, in their own name, for one or more profiles. Several experts may be retained under the same profile, according to needs.

Selection and contracting are carried out on an individual basis. Contracts are concluded individually with each expert (man-day framework contracts, activated by purchase orders according to needs), and not with consulting firms. Experts affiliated with a firm, an institute or a network may apply in their own name and are assessed on their individual CV and references. An expert who does not have a structure for invoicing purposes may be administratively hosted by an organisation of his or her choice (hosting/portage arrangement): in that case, the contract and the purchase orders still designate the expert by name, the expert remains personally responsible for the deliverables, and no substitution is permitted without the prior written approval of Expertise France.

Project or context description

Context

Substandard and falsified medical products (SFMP) constitute a major health, economic and security threat in Africa. The World Health Organization estimates that one in ten medical products circulating in low- and middle-income countries is substandard or falsified, causing more than 250 000 preventable deaths per year. In response to this challenge, the European Union and Expertise France are implementing the MEDISAFE programme.

MEDISAFE Phase 1 (2018-2023) covered 11 countries in East and Central Africa (Burundi, DRC, Ghana, Ethiopia, Seychelles, Kenya, Uganda, Tanzania, Malawi, Rwanda and Zambia). It produced the Reference Manual on SFMP legislation (African perspective), guides and strategies on supply chain, legislation and communication, as well as the roadmap adopted in Nairobi in April 2022. It brought together more than 300 participants across 14 regional and national events, in partnership with the European Union (CBRN network), UNODC, INTERPOL, the Council of Europe and AUDA-NEPAD.

MEDISAFE 2.0 extends and broadens this first phase: a four-year project, funded by the European Union (NDICI) for a total amount of EUR 9 000 000, implemented by Expertise France under indirect management via a contribution agreement with the European Union Delegation in Nigeria. It covers 13 countries organised into two regional clusters.

Cluster A (West Africa): Benin, Côte d'Ivoire, Ghana, Guinea (Conakry), Nigeria, Senegal, Togo.

Cluster B (East and Southern Africa): Burundi, Democratic Republic of the Congo, Ethiopia, Kenya, Rwanda, Zambia.

In line with the action document's approach, the project distinguishes the countries that benefited from MEDISAFE Phase 1, seven of the 13: Ghana, Burundi, DRC, Ethiopia, Kenya, Rwanda and Zambia, from the newly added countries. It combines activities tailored to the maturity level of the new countries, capitalisation and consolidation activities for the former, and cross-cutting regional activities bringing the two groups together (peer mentoring, experience-sharing, operational coordination).

Overall objective: Mitigate the health, economic and security threats posed by substandard and falsified medical products (SFMP) in West and East Africa.

The project pursues this objective through three complementary specific objectives, linked within a single theory of change and all embodying an inclusive and gender-sensitive approach:

•     SO1 - National and regional legal capacities to combat SFMP are strengthened through an inclusive and gender-sensitive harmonisation of legal frameworks and the implementation of key regulations.

•     SO2 - The capacity of national and regional law enforcement actors to detect, investigate and combat SFMP is strengthened through the optimisation of inclusive operational procedures, improved intelligence and the development of transnational cooperation responding to the specific needs of the most vulnerable, in particular women and children.

•     SO3 - The supply chain is strengthened and secured, and public awareness of SFMP is increased, through inclusive and gender-sensitive approaches, by promoting the active role of women health professionals, women-led organisations and caregivers, in order to ensure people's safety and equitable access to safe and effective medical products.

These terms of reference fall under the pharmaceutical component (SO3), to which two outputs contribute:

•     Output 3.1 - Civil society actors have raised their level of awareness and strengthened their knowledge, risk perception and preventive behaviours regarding SFMP, pharmaceutical crime and digitally enabled forms of trafficking.

•     Output 3.2 - Partner countries establish and operationalise risk-based systems for traceability, post-market surveillance and regulatory control of medical products, in order to prevent, detect and respond to the circulation of SFMP in national and cross-border supply chains.

The project is entering its four-month inception phase, the culmination of which is the MEDISAFE 2 Action Plan validated by the countries and Expertise France, to be submitted to the European Union Delegation. Gender-sensitive approaches, in particular accounting for the differentiated exposure of women, men and vulnerable populations, and promoting the role of women health professionals and women-led organisations, are integrated in a cross-cutting manner.

Required profile

Profiles sought

Each profile below specifies the purpose of the support, the expected competencies and the indicative volume. Profiles C and D may be covered by the same expertise; profiles B, E, F and G fall under targeted mobilisation according to the needs validated by country. For all profiles, familiarity with the WHO Global Benchmarking Tool (GBT) sub-indicators relevant to the profile is an asset.

 

A - Supply chain security and traceability expert

Purpose of the support: Support the supply chain security assessments (based on the MEDISAFE Supply Chain Security guide) of at least the eight countries prioritised in Year 1 (Kenya, DRC, Côte d'Ivoire, Benin, Guinea; self-assessment for Zambia, Burundi, Nigeria), whose findings feed the NAP pathway; develop the traceability procedures (SOPs) and support the integration of traceability and verification solutions (TRVST experience in Nigeria, Rwanda).

 

Expected competencies:

•     Higher degree and proven experience of the pharmaceutical supply chain (PSM).

•     Command of traceability and serialisation standards (GS1) and of verification solutions.

•     Experience of supply chain security assessments and of developing SOPs in an African context.

Indicative volume: ≈ 15 days over the inception phase, extensible according to the country’s needs

 

B - Good Manufacturing, Storage and Distribution Practices (GMP/GDP) expert

Purpose of the support: Support the assessment and strengthening of good manufacturing practices among local manufacturers, in conjunction with the regulatory authorities and prequalification processes, only where this priority is selected and validated by the country and without the support amounting to certification. Under the same conditions, support the assessment and strengthening of quality management systems (WHO MQAS type) and of good storage and distribution practices among targeted supply chain actors (importers, wholesalers, distributors, procurement agencies).

 

Expected competencies:

•     GMP and GDP inspector qualification or recognised equivalent experience.

•     Experience of supporting pharmaceutical production sites and distribution/storage facilities, and command of the WHO and PIC/S reference frameworks (GMP, GDP QAMS).

•     Ability to train and transfer skills to national inspectors and others NRA actors.

Indicative volume: As required (targeted mobilisation)

 

C - Post-market surveillance (PMS) and vigilance expert

Purpose of the support: Develop risk-based market surveillance plans (one per subregion), define the sampling protocols, support the use of the results and strengthen the linkage with national vigilance systems (reporting and signal management).

Expected competencies:

•     Proven experience of post-market surveillance of medical products.

•     Command of risk-based approaches and of the detection technologies recommended by the WHO.

•     Knowledge of vigilance systems for medical products (reporting, signal detection and risk communication).

•     Experience of NMRA - laboratory - field coordination.

Indicative volume: ≈ 15 days (shared with profile D, extensible according to the country’s needs)

 

D - Quality control laboratory (QCL) expert

Purpose of the support: Support the strengthening of the national quality control laboratories: analytical practices, linkage with market surveillance, progression towards recognition and prequalification.

Expected competencies:

•     Experience of a pharmaceutical quality control laboratory and of the WHO-GPQCL, ISO/IEC 17025 standards.

•     Knowledge of detection technologies and of the WHO Global Benchmarking Tool (GBT).

•     Ability to support national laboratories in Africa.

Indicative volume: shared with profile C (extensible according to the country’s needs)

 

E - Online pharmacy regulation and pharmaceutical cybercrime expert

Purpose of the support: Support the regulatory oversight of online medicine sales (framework, SOPs, reporting mechanisms), in close interface with the Law Enforcement pillar and the cyber units.

Expected competencies:

•     Experience of regulating e-commerce in health products.

•     Knowledge of digital evidence issues and of cooperation with law enforcement services.

•     Ability to link the regulatory and law enforcement dimensions.

Indicative volume: ≈ 12 days (targeted mobilisation, extensible according to the country’s needs)

 

F - National SFMP action plan (NAP) development and multisectoral coordination expert

Purpose of the support: In countries where the development of a national action plan (NAP) against SFMP is prioritised, facilitate the multisectoral development of the NAP based on the WHO handbook, building on the findings of the supply chain security assessments, up to the national validation workshops and the articulation with the AMRH continental framework.

Expected competencies:

•     Proven experience of facilitating national health strategies or action plans, ideally NAPs against SFMP based on the WHO handbook.

•     Strong multisectoral facilitation skills (health, justice, customs, law enforcement, private sector, civil society).

•     Knowledge of the African regulatory landscape (AMRH, AMA, regional economic communities).

Indicative volume: As required (targeted mobilisation from Year 1, following the supply chain security assessments; extensible according to the country’s needs)

 

G - Regulatory systems strengthening, quality management and WHO GBT expert

Purpose of the support: Support the national regulatory authorities in strengthening their regulatory systems and their quality management (ISO 9001-type QMS, continuous improvement culture), using the WHO Global Benchmarking Tool (GBT) as the common reference: reading of the Institutional Development Plans in GBT terms, mapping of country priorities onto the GBT sub-indicators most directly linked to preventing, detecting and responding to SFMP (market surveillance and control, vigilance, regulatory inspection, licensing of establishments, laboratory testing, regulatory system), and preparation for (re)benchmarking so that project deliverables contribute to maturity level progression. This support does not substitute for formal WHO benchmarking, and an expert supporting a country under this profile may not act as a WHO assessor for that same country.

Expected competencies:

•     Proven experience of regulatory systems strengthening with national regulatory authorities in Africa; GBT qualification (WHO-trained expert or assessor) or equivalent documented practice.

•     Experience of implementing quality management systems and continuous improvement approaches within public institutions, ideally regulatory authorities.

•     Ability to link GBT sub-indicators, Institutional Development Plans and national action plans into operational priorities.

Indicative volume: As required (targeted mobilisation according to the priorities validated by country under the IDP/NAP pathway)

Additional information

Procedure

Selection of individual experts through this call for expressions of interest, in accordance with Expertise France's procurement rules (assessment of CVs, references and fee proposals); possible application for one or more profiles; contracting lead time to be anticipated from inception where the service supports Year 1 activities.

Reporting line

Pharmaceutical Component Lead (Technical Expert, Pharmaceutical Regulation and Supply Chain Security)

Working languages

French and/or English depending on the countries of intervention

Application

CV of the expert (individual application) + references of comparable assignments + short methodological note + proposed daily fee rate + where applicable, identification of the hosting organisation (portage)

Selection criteria for applications

The selection process for candidates will be based on the following criteria :

  • Candidate’s training/skills/experience
  • Candidate’s training/diplomas related to the expert assignment
  • Candidate’s skills linked with the expert mission
  • Candidate’s experiences linked with the expert mission
  • Candidate’s expected linguistic understanding

Deadline for application : 2026/08/15 23:59

File(s) attached : TdR_3_Pool_consultants_TA_EN_KH_V3.docx

Expertise France is the public agency for designing and implementing international technical cooperation projects. The agency operates around four key priorities :

  • democratic, economic, and financial governance ;
  • peace, stability, and security ;
  • climate, agriculture, and sustainable development ;
  • health and human development ;

In these areas, Expertise France conducts capacity-building initiatives and manages project implementation, leveraging technical expertise and acting as a project coordinator. This involves combining public sector expertise with private sector skills to drive impactful results. 

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