International Consultant - Market Surveillance and Control

The International Consultant will support Member States and regional networks, especially the South-East Asia Regulatory Network (SEARN), in preventing, detecting, and responding to substandard and falsified medical products through strengthened Global Surveillance and Monitoring System (GSMS) reporting, incident management, risk communication, and capacity building. The role involves technical assistance, coordination with regional partners, incident analytics, risk communication, training, and reporting activities.

Responsibilities

• Provide technical assistance in developing and implementing National Action Plans related to substandard and falsified medical products.
• Support the development and implementation by National Regulatory Authorities (NRAs) of incident reports and risk-based inspections.
• Support collaboration between NRAs to optimize GMP inspections.
• Support delivery of technical assistance to national quality control laboratories including on-site visits, twinning programmes, and peer-learning initiatives.
• Enable NRAs to publish IVD field safety notices and corrective actions using structured formats aligned with IMDRF datasets.
• Contribute to planning, monitoring, and evaluation of risk-based post-market surveillance activities and laboratory capacity-strengthening efforts.
• Support development of collaboration with regional regulatory authorities and laboratory networks including SEARN.
• Coordinate day-to-day GSMS focal-point engagement, onboarding, mentoring, and meetings.
• Support joint activities with partners such as UNODC, WCO, WOAH, Interpol, and academic laboratories.
• Coordinate regional reporting to GSMS and SEARN and support incident management related to substandard and falsified medical products.
• Support data uploads, curation, validation, and media/signal scanning to improve data quality and risk assessments.
• Produce localized threat assessments and thematic briefs for authorities and networks.
• Adapt and disseminate global risk communication tools to regional contexts and support country-level risk communication plans.
• Organize and contribute to regional training sessions using the SF toolkit and other materials.
• Contribute to development, dissemination, and evaluation of training materials and technical resources.
• Monitor and evaluate training programme delivery and impact.
• Support establishment and development of WHO Collaborating Centres and SEARN Regional centres of excellence.
• Provide input into regional planning and reporting processes and submit quarterly KPI updates and reports.
• Perform other relevant duties as assigned by supervisors.
• Deliver comprehensive technical and administrative support across budget centers and strengthen country office capacity through engagement and collaboration.

Requirements

• Advanced university degree in pharmacy, chemistry, biochemistry, microbiology, or a related health or life sciences field.
• Five to ten years of relevant professional experience in medical product market surveillance, pharmaceutical quality assurance, including experience in strengthening regulatory/laboratory systems and regulatory inspections or working with medical products manufacturing industry and setting up active market surveillance systems for manufacturers and GMP.
• Experience with post-market surveillance for IVDs/devices; incident coding and data systems; laboratory QA for for-cause testing is desirable.
• Significant experience in South-East Asia is desirable.
• Strong analytical and communication skills.
• IT/data literacy including spreadsheets, dashboards, and analytics.
• Risk-communication competencies.
• Stakeholder engagement skills.
• Expert knowledge of English.
• Expert knowledge of South-East Asian language(s) is desirable.

Skills

• Medical Product Market Surveillance
• Pharmaceutical Quality Assurance
• Regulatory Inspection
• Regulatory Strengthening
• Active Market Surveillance Systems
• Good Manufacturing Practices
• Post-Market Surveillance for IVDs
• Incident Coding and Data Systems
• Laboratory Quality Assurance
• Risk Communication
• Stakeholder Engagement
• Data Analysis
• Spreadsheets
• Dashboard Development
• Analytics
• Technical Assistance
• Training Delivery
• Reporting
• English Language Proficiency

Languages

English