Chargé(e) technique - Surveillance et contrôle du marché
Organizational Context
The World Health Organization (WHO), a specialized agency of the UN since 1948, aims to bring all peoples to the highest possible level of health. WHO leads in health matters, sets research priorities, establishes norms, provides technical support, and monitors health trends. This role supports Member States in strengthening their capacities for preventing, detecting, and managing substandard and falsified (SF) medical products, including in vitro diagnostics (IVDs) and other medical devices.
Job Purpose
This role supports Member States in enhancing their capabilities to prevent, detect, and manage substandard and falsified (SF) medical products, including in vitro diagnostics (IVDs) and other medical devices. This will be achieved through strengthening reporting in the Global Surveillance and Monitoring System (GSMS), incident management, risk communication, risk-based post-market surveillance (rbPMS) activities, and building capacity of quality control laboratories (QCL). The incumbent will coordinate and mobilize relevant technical experts as needed to ensure the effective implementation of planned activities, contributing to the overall goal of ensuring the quality and safety of medical products.
Responsibilities
Provide technical assistance to Member States for implementing national action plans on SF medical products. Support national quality control laboratories (NQCLs) through site visits, twinning, and peer learning. Enable national regulatory authorities (NRAs) to issue field safety notices (FSNs) and field safety corrective actions (FSCAs) for IVDs using structured formats. Assist in establishing and improving national medical device incident databases and associated analytical tools. Contribute to planning, monitoring, and evaluating risk-based post-market surveillance of SF medical products and laboratory capacity building for integration into WHO's WLQCL program. Coordinate regional networks and partnerships with regulatory authorities and laboratory networks, managing daily exchanges with focal points and supporting joint activities with partners like UNODC, WCO, WOAH, INTERPOL, and academic labs. Oversee the GSMS reporting and SF medical product incident management at the regional level, supporting data validation, risk assessment, and thematic briefings. Adapt and disseminate global risk communication (RC) tools, support national RC plans, and provide enhanced incident support. Organize and contribute to regional training sessions, develop and evaluate training materials, and monitor program implementation and impact. Contribute to regional planning and reporting processes, ensuring timely documentation of activities and results, and submit quarterly KPI updates.
Work Experience
Minimum of 7 years of professional experience, including at least 5 years in market surveillance and control of medical products, and pharmaceutical quality assurance. Demonstrated experience in strengthening regulatory or laboratory systems is required. Desirable experience includes post-market surveillance of IVDs and medical devices, incident coding, data management systems, and laboratory quality assurance for incident-related analyses.
Skills
Strong analytical and communication skills, proficiency in IT tools and data management (spreadsheets, dashboards, analysis tools), risk communication, and stakeholder engagement. Good understanding of drug and vaccine regulatory systems, and post-market surveillance and control principles. Teamwork, respect for diversity, results-orientation, and efficient resource utilization are also essential.