UNICEF recrute un consultant en réglementation des vaccins (nationaux), Lesotho

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Background and Justification :

In preparation for COVID-19 vaccine introduction, Lesotho as part of the COVAX AMC countries has applied for support under the COVAX facility to introduce the COVID-19 vaccine. It is anticipated that the vaccine will be available in the country by the second quarter of 2021. To ensure that the country is ready to receive the vaccine, there are a number of processes, approvals and documents requested from the country. Part of the requirements from the country is to ensure that regulatory processes have been followed and received necessary approvals (including waivers where necessary) before the vaccines are shipped into the country.

To facilitate this effort and ensure country readiness in a timely manner with the necessary documentation, UNICEF is supporting the Ministry of Health to obtain all information and documents which will facilitate receipt of the COVID-19 vaccine.

The consultancy therefore is for an individual contractor who will work with the vaccine, cold chain and logistics sub-group of the New Vaccine Introduction Technical Working Group (NVITWG), EPI Program, and pharmaceutical department of the Ministry of health to collect and obtain all required documents. The contractor will work closely with the NVITWG and engage other departments as necessary to meet terms of reference of the contract

Scope of Work  :

Goal and Objective : The consultant will work closely with the National Logistics Working Group (NLWG) to follow all the processes outlined by the pharmaceutical department to obtain regulatory authorization and documentation that allows the COVID-19 vaccine into the country.

Provide details/reference to AWP areas covered : The assignment for the consultancy will contribute to the achievement of Child Survival and Development Output 1.1.3 Provide technical and financial support for forecasting, procurement, and management of vaccines, supplies and cold chain equipment.

Activities and Tasks : The consultant will perform the following specific functions.

Define regulatory mechanism to recognize or to rely on WHO Prequalification or Emergency Use Listing

Define regulatory mechanism to recognize or to rely on Stringent Regulatory Authorization (Marketing Authorization or Emergency approval)

Provide expedited regulatory pathways for approval of COVID-19 medical products (therapeutics and vaccines) other than reliance on WHO Emergency Use Listing, WHO Prequalification and/or SRA marketing authorization or emergency approval

Provide a list of requirements and minimum documents needed for defined regulatory approvals of COVID-19 vaccines under emergency or expedited pathways

Advise a system to waive lot release testing based on review of summary protocols in place.

Identify the requirement and documents needed for NRA lot release or waiver of lot release for COVID-19 vaccines. Timelines for lot release/waiver process should be mentioned

Collect all documents needed to obtain Import permits

Work relationships :

Under the overall Supervision of the Chief, CSD, and technical guidance from the Cold Chain officer, UNICEF, the consultant will work very closely with the relevant departments and technical staff of the MoH. The consultant will be embedded within the MoH team for the duration of the assignment meaning that he/she will sit in the EPI office in the MoH and work alongside the EPI team the entire duration of the consultancy. The Consultant is expected to work independently and take end-to-end responsibility for the deliverables in the contract.

 Payment schedule : Payment will be made upon successful delivery of planned deliverables, as approved by UNICEF and the MoH.

Desired profile :

Qualifications : Bachelor or Masters in Pharmacy, Public Health or Health Supply Chain.

Experience : At least 5 years of experience at the national level on supply chain management, cold chain management, logistics or operations management, immunization/public health programmes.

Familiarity with cold chain systems, effective vaccine management, inventory policies, logistics, outsourcing, segmentation strategies, integration of health products, and other system design strategies

Proven ability to conceptualize, innovate, plan and execute ideas.

Computer skills, including quantitative analysis and reporting tools.

Competencies: Good communication, working with people, drive for results, and planning and organizing;

Language : Fluency in written and spoken English required.

Consultant Work Place :

The consultant will be based at the Ministry of health siting in the EPI office. The consultant should bring his/her own computer/laptop. No travel is expected out of Maseru and the consultant is encouraged to work from home as much as possible. Virtual meetings are also encouraged to practice social distancing as much as possible.

Administrative Issues :

• The selected consultant will be governed by and subject to UNICEF General Terms and Conditions ;
• The consultant will work on their own computer(s) and use their own office resources and materials in the execution of this assignment ;
• The consultant fees must be all inclusive of all administrative costs ;
• The consultant is expected to be available and fully in charge of delivering the deliverables during the contract period ;
• As per UNICEF DFAM policy, payment is made against satisfactory completion of deliverables as per the approved work plan. No advance payment is allowed unless in exceptional circumstances against bank guarantee, subject to a maximum of 30 per cent of the total contract value in cases where advance purchases, for example for supplies or travel, may be necessary.

Risks :

UNICEF Lesotho 2019-2022 Country Programme Document (CPD) was developed with a risk-informed programming lens to support sustainable programs, considering assumptions for the pro-jects success. The development of the CPD, through which this activity will contribute to, analysed the vulnerabilities, systems, capacities, resources, and looked at the risks beneficiaries may face to prevent the risk or mitigate the impact. The risks associated with the implementation of this activity are minimal and below the global threshold set by UNICEF Eastern and Southern Africa Regional Office. The risks will be managed through constant monitoring, providing early warning of potential issues in programme implementation, and advocacy with GOL officials. All reasonable and likely risks should be identified and a relevant risk response and possible mitigating action defined

How to Apply :

Qualified candidates are requested to complete an application including profile to the respective advertisement on  https://www.unicef.org/about/employ/ Please indicate your ability, availability and financial proposal/quote to complete the terms of reference above.

Rates must be submitted in the local currency and include all expenses related to the assignment (e.g. consultancy fee, travels, living allowance for field trips only).

Submission of proposals :

Interested persons will be required to submit the following documents:

1. A cover letter, CV and online consultants application form ;
2. A financial proposal indicating deliverable based fee at daily rate in LSL ;
3. The financial proposals of only those candidates, who are found technically responsive, will be opened ;
4. Please note, offers without financial proposal will not be considered ;
5.  Any attempt to unduly influence UNICEF selection process will lead to automatic disqualification of the applicant.

If you have not been contacted within 2 months of the closing date please accept that your application was unsuccessful. Regret emails will be sent only to shortlisted/contacted candidates.

UNICEF is committed to diversity and inclusion within its workforce, and encourages all candidates, irrespective of gender, nationality, religious and ethnic backgrounds, including persons living with disabilities, to apply to become a part of the organization.

UNICEF has a zero-tolerance policy on conduct that is incompatible with the aims and objectives of the United Nations and UNICEF, including sexual exploitation and abuse, sexual harassment, abuse of authority and discrimination. UNICEF also adheres to strict child safeguarding principles. All selected candidates will be expected to adhere to these standards and principles and will therefore undergo rigorous reference and background checks. Background checks will include the verification of academic credential(s) and employment history. Selected candidates may be required to provide additional information to conduct a background check.

Remarks :

Mobility is a condition of international professional employment with UNICEF and an underlying premise of the international civil service.

Only shortlisted candidates will be contacted and advance to the next stage of the selection process.

Individuals engaged under a consultancy or individual contract will not be considered “staff members” under the Staff Regulations and Rules of the United Nations and UNICEF’s policies and procedures, and will not be entitled to benefits provided therein (such as leave entitlements and medical insurance coverage). Their conditions of service will be governed by their contract and the General Conditions of Contracts for the Services of Consultants and Individual Contractors. Consultants and individual contractors are responsible for determining their tax liabilities and for the payment of any taxes and/or duties, in accordance with local or other applicable laws.