International Consultant - Market Surveillance And Control

Organizational Context

The World Health Organization (WHO) assists Member States in strengthening regulatory capacity to combat substandard and falsified medical products. This role, within the SE/HSD Department of Health Systems Development, focuses on prevention, detection, and response strategies to ensure the quality, safety, and efficacy of medicines and medical devices.

Job Purpose

The International Consultant - Market Surveillance and Control will support Member States and regional networks, particularly the South-East Asia Regulatory Network (SEARN), in combating substandard and falsified (SF) medical products. This involves strengthening the Global Surveillance and Monitoring System (GSMS) through enhanced reporting, incident management, risk communication, and post-market surveillance. The role also focuses on promoting Good Practices (GxPs) compliance and enabling national quality control laboratories to improve the overall safety and efficacy of medical products in the region.

Responsibilities

Provide technical assistance to Member States for developing and implementing National Action Plans against SF medical products. Support National Regulatory Authorities (NRAs) in developing and implementing incident reports, risk-based inspections, and inter-NRA collaboration for GMP inspections. Assist in delivering technical assistance to national quality control laboratories, including on-site visits and peer-learning. Enable NRAs to publish field safety notices and corrective actions in standardized formats. Contribute to planning, monitoring, and evaluating risk-based post-market surveillance and laboratory capacity strengthening. Coordinate regional reporting to GSMS and SEARN, supporting NRAs and WHO in incident management. Support data uploads, curation, and validation for GSMS, and conduct local threat assessments. Coordinate regional network engagement, onboarding, and meetings for GSMS focal points. Support joint activities with international partners.

Work Experience

Essential: 5-10 years of relevant professional experience in medical product market surveillance and pharmaceutical quality assurance. This includes experience in strengthening regulatory/laboratory systems, regulatory inspections, or establishing active market surveillance systems and GMP. Desirable: Experience with post-market surveillance for IVDs/devices, incident coding, data systems, laboratory QA, and significant experience in South-East Asia.

Skills

Essential: Strong analytical and communication skills, IT/data literacy (spreadsheets, dashboards, analytics), risk-communication competencies, stakeholder engagement. Expert knowledge of English. Desirable: Expert knowledge of South-East Asian language(s).

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