Specialist, QA Monitoring, Vigilance & Market Surveillance - GL D - Defined Duration until December 2028

Specialist, QA Monitoring, Vigilance & Market Surveillance - GL D - Defined Duration until December 2028

The Global Fund aims to accelerate the end of AIDS, tuberculosis (TB) and malaria as epidemics. As part of our mandate to fight the three diseases, the Global Fund plays a leading role in global markets for medicines and technologies that prevent, diagnose, and treat HIV, Tuberculosis and Malaria. Every year, more than half of the Global Fund's investments is used to procure key health products, ensuring they are available to those who need them most.

As one of the biggest health product procurement entities in the public sector, investing nearly US$3 billion in health products and equipment procurement, the Global Fund is uniquely placed to drive equitable access to quality-assured health products, services and innovations through its Supply Operations department.

Supply Operations, collaborating across the Global Fund Secretariat, is responsible for the Global Fund's market shaping activities and the overall management of health product sourcing, procurement, quality assurance and supply chains.

The Quality Assurance & Compliance team plays a key function in ensuring safe access and delivery of quality assured health products to the communities and people we serve. This mission is implemented by enabling program and operational requirements, while mitigating residual risks associated with quality, safety and efficacy of health products procured with Global Fund funds through clearly established procedure, governance model and case management. The team works with external technical partners to keep the organization abreast of evolving matters related to health products QA requirements and compliance across public health sector.

The Specialist, QA Monitoring, Vigilance & Market Surveillance works under the supervision of the Manager, Product & Supplier QA Compliance. The Specialist supports the Global Fund's mission by ensuring robust market surveillance and vigilance approaches are in place to monitor the quality, safety and efficacy of health products throughout their lifecycle. They ensure timely and appropriate management of health product related incidents downstream (post-shipment), with the assistance of the Associate Specialist, QA Case Management.

They analyze data and trends on all types of quality or safety or efficacy/poor performance information signals which can be of interest to assess potential risk for the quality of health products procured with The Global fund funds.

Based on information gathered and data analysis implemented, they propose, advise and support the implementation of the market surveillance strategy and programs in line with the emerging risk identified.

They contribute to country regulatory strengthening activities on vigilance and market surveillance.

Key Responsibilities

Policy and guidance

• Contribute to the development and enhancement of The Global Fund's (TGF) QA policies, guidelines and governance model.
• Provide advice and support at all stages of grant design and implementation.
• Contribute to the development of technical brief(s) or other supportive guidance documents to help applicants prepare their funding requests.

QA Monitoring, Market Surveillance & Vigilance

• Contribute to the technical support provided to countries in order to ensure implementation of TGF Market surveillance and vigilance activities.
• Support QA compliance monitoring activities by linking vigilance findings with broader product quality assurance efforts, including supplier and PSA compliance verification.
• Working closely with the Associate Specialist, QA Case Management, lead the analysis of quality and safety signals, and contribute to risk mitigation strategies in collaboration with country teams and the QA & Compliance team.
• Analyze data and potential trend on all types of quality or safety or efficacy/poor performance signals.
• Contribute to the assessment of potential risk for the quality of health products procured with TGF funds in close collaboration with the relevant health product QA Specialist.
• Propose, advise and support implementation of market surveillance strategy and programs in countries in line with the emerging risk(s) identified and ensuring market surveillance activities or safety events are reported to Global Fund QA.
• Contribute to country capacity building by supporting the development of national vigilance systems, training programs, and regulatory frameworks for market surveillance.
• Contribute to the selection of service providers on Regulatory, Quality Assurance and quality control matters including market surveillance and vigilance.
• They lead the investigations of quality complaints, safety events and other quality challenges experienced by Global Fund Principal Recipients and advise QA Team Lead on optimal risk-mitigation measures
• Coordinate the product recalls with internal stakeholders and national regulatory bodies in case of non-compliance of healthcar

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