Background

South Sudan signed the New Funding Model 3 (NFM3) HIV/RSSH/TB grant in December 2020. The NFM3 grant covers the implementation period from January 2021 to December 2023. It is important to note that the 2020-2023 GFATM grant cycle prioritizes high impact interventions and activities to address HIV, TB, and Resilient Systems for Sustainable Health (RSSH) issues in South Sudan. 

UNDP has been the Principal Recipient (PR) of the Global Fund grants on behalf of the Government of South Sudan since 2004 when the Global Fund's Additional Safeguards Policy was applied limiting the role of national entities to function in this capacity. Since then, working in partnership with the Ministry of Health, UNDP has been managing the Global Fund HIV, TB and RSSH grants. In addition; UNDP has been supporting the Ministry of Health in the management of the warehouse for pharmaceutical commodities, distribution of commodities as well as provision of technical assistance. South Sudan has enormous supply chain issues ranging from proper stock management at the facility level including appropriate storage capacity including temperature control, rational drug use, and inventory management.

Ppharmacovigilance is defined as the ‘science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem’. The aim of pharmacovigilance is to bolster patient safety concerning medicine use by providing a system to collect, assess, and distribute drug safety data. Pharmacovigilance activities involve monitoring approved drugs and investigational medicinal products. Post market surveillance and drug efficacy testing ensures availability of quality medicines and reduces non recommended drugs and counterfeits.

Duties and Responsibilities

The purpose of the assignment is to support the MOH to develop and update South Sudan Pharmacovigilance existing tools in order to improve the protection of health and safety of patients, users and others by reducing the likelihood of reoccurrence of incidents related to the use of medical or other healthcare products

The international consultant will work with MOH and UNDP focal points to carry out the following tasks:

• Developing norms, standards and guidelines.
• Providing credible safety and regulatory information on medicines.
• Appointing and convening global advisory committees of experts to review and provide guidance on the safety of medicines and vaccines.
• Providing training programmes to build and strengthen the capacity of national safety surveillance systems for medicines and vaccines.
• Developing innovative methods and tools to generate new evidence on the safety of medicinal products
• Develop and validate Standard Operating Procedures (SOPs) to cover all expected functions of the Pharmacovigilance. This includes working with relevant stake holders in the pharmaceutical sector to design templates and to document reporting processes for routine and programmatic reporting for Ministry of Health/DFCA. The SOPs should also, where relevant, follow existing rules and procedures for the MOH as well as be fully compliant with WHO pharmacovigilance policy.
• Organize Training of trainers on pharmacovigilance aspects including but not limited to developing the training curriculum for training of healthcare workers across the country. The curriculum will include trainer’s manual, participants manuals and implementation guide.

The consultant will be expected to submit the following deliverables:

• Inception report with findings of rapid situational analysis and detailed
• SOP manual developed covering all aspects of the pharmacovigilance, including the detailed requirements for programmatic reporting.

Final training consultancy report

Applicants will be evaluated based upon their submitted expressions of interest and financial proposals, which includes a cumulative analysis method based upon a combination of technical and financial evaluation results.

Individual consultants will be evaluated based on the following’s methodology:

Cumulative analysis

When using this weighted scoring method, the award of the contract shall be made to the individual consultant whose offer has been evaluated and determined as:

• Responsive/compliant/acceptable; and
• Having received the highest score out of a pre-determined set of weighted technical and financial criteria specific to the solicitation.
• Relevant Education
• Relevant Experience
• Competency

* Technical Criteria weight; [70%]

* Financial Criteria weight; [30%]

To be computed as a ratio of the Proposal’s offer to the lowest price among the proposals received by UNDP.

Competencies

Corporate Competencies

• Demonstrates integrity by modeling the UN’s values and ethical standards;
• Promotes the vision, mission, and strategic goals of UNDP;
• Displays cultural, gender, religion, race, nationality and age sensitivity and adaptability.

Functional Competencies:

• Strong analytical, negotiation and communication skills, including ability to produce high quality practical advisory reports and knowledge products;
• Professional and/or academic experience in one or more of the areas of international development, public health or related field.

Project and Resource Management:

• Ability to produce high quality outputs in a timely manner while understanding and anticipating the evolving client needs.
• Strong organizational skills;
• Ability to work independently, produce high quality outputs.

Communications and Advocacy:

• Strong ability to write clearly and convincingly, adapting style and content to different audiences and speak clearly and convincingly;
• Strong analytical, research and writing skills with demonstrated ability to think strategically;
• Strong inter-personal, negotiation and liaison skills.

Language:

Excellent oral and written English

Required Skills and Experience

• A Masters’ Degree in Pharmacy, or Bachalar Degree in Pharmacy with a minimum 10 years of working experience on issues related to pharmaceutical sector strengthening for the public sector.
• Knowledge of pharmacovigilance and ability to apply knowledge to evaluation of safety concerns and minimization of patient risk throughout the life cycle of a drug product
• Experience of working with /or substantial knowledge of the Global Fund for HIV, TB and Malaria grants management requirements.
• Experience working with and supporting Ministries of Health in developing countries.
• Strong understanding of the South Sudanese public health and pharmaceutical sector is preferred.
• Relevant work experience in capacity development of institutions in the context of strengthening national systems is required, including the development of standard operating procedures (SOPs) and other tools for effective management of health programmes.
• Written and verbal fluency in English is essential
• Experience in working for an international organisation and/or UNDP is required.
• Experience in facilitating training and mentoring processes, particularly in cr0ss-cultural environments is required.