Overview
Support Member States and regional networks in preventing, detecting, and responding to substandard and falsified medical products through strengthened GSMS reporting, incident management, and risk communication.
Key Responsibilities
- Provide technical assistance to Member States in developing and implementing National Action Plans related to SF medical products.
- Support the development and implementation of incident reports and risk-based inspections by NRAs.
- Support the delivery of technical assistance to national quality control laboratories.
- Enable NRAs to publish IVD field safety notices (FSNs) and Field safety corrective actions (FSCAs).
- Contribute to the planning, monitoring, and evaluation of SF risk-based post-market surveillance activities.
- Support the development of collaboration with regional regulatory authorities and laboratory networks.
- Coordinate day‑to‑day GSMS focal‑point (FP) engagement, onboarding, mentoring, and regional/subregional FP meetings.
- Contribute to supporting joint activities with partners.
- Coordinate regional reporting to GSMS and SEARN, and provide support to NRAs and WHO in incident management.
- Support uploads, curation and validation of reports, and local media/signal scanning.
- Produce localized threat assessments and thematic briefs.
- Adapt and disseminate global risk communication tools to regional contexts.
- Support country‑level risk communication plans and provide surge support during incidents.
- Organize and contribute to regional training sessions.
- Contribute to the development, dissemination, and evaluation of training materials.
- Monitor and evaluate the delivery and impact of training programmes.
- Support the establishment, maintenance and development of activities of related WHO Collaborating Centres.
- Provide input into regional planning and reporting processes.
- Submit quarterly KPI updates, contribute to After‑Action Reviews (AARs), and support biennium reporting.
- Perform any other relevant duties assigned by supervisors.
Required Experience
- Five to ten years of relevant professional experience in medical product market surveillance, pharmaceutical quality assurance, including either demonstrated experience in strengthening regulatory / laboratory systems and regulatory inspections experience, or working with medical products manufacturing industry and having significant experience in setting up active market surveillance system for manufacturers and GMP.
- Desirable: Experience with post‑market surveillance for IVDs/devices; incident coding and data systems; laboratory QA for for‑cause testing. Significant experience in South-East Asia.
Qualifications
Advanced university degree in pharmacy, chemistry, biochemistry, microbiology, or a related health or life sciences field.
