Regulatory System Strengthening – Pharmacovigilance

BACKGROUND

Strengthening pharmacovigilance system is one of the critical elements to assure safety and safe use of health technologies (devices, medicines, vaccines, procedures and systems) in patients and populations. Persisting challenges in the past have been aggravated by COVID-19 pandemic including under-reporting, delays in timely investigations, incomplete causality assessment and lack of resources.

While the national regulatory authorities monitor the safety of medicines, surveillance of adverse events following immunization (AEFI) is often conducted by national immunization programmes. Weak reporting and management of AEFI have diminished trust in vaccine programmes and sometimes resulted in reluctance to adopt vaccines. The Contractual Partner will support various strategies aimed at building or strengthening PV system in low and middle-income countries, to ensure their pharmacovigilance preparedness through enhanced capacity for the identification, assessment and management of any risk associated with new medical products especially for the COVID-19 vaccines.

PURPOSE/SPECIFIC OBJECTIVE OF THE ACTIVITY

To support the regulatory systems strengthening programme within EMT team in the development and implementation of strategies and actions in strengthening Member States' pharmacovigilance system with focus on COVID-19 vaccine introduction in the Western Pacific Region.

DESCRIPTION OF ACTIVITIES TO BE CARRIED OUT

The contractual partner will work with EMT mainly and closely coordinating with Vaccine-Preventable Diseases and Immunization team and will carry out the following:

Output/s

Output 1: Situational analysis

Deliverable 1.1: Concept paper (Part 1) detailing the situational analysis of pharmacovigilance systems in the region and projected issues on covid-19 vaccines post marketing surveillance.

Output 2: Lead the development of regional position paper regarding the preparedness strategies and implementation.

Deliverable 2.1: Concept paper (Part 2) for strategies to strengthen pharmacovigilance systems in accordance to the situational analysis.

Output 3: National capacity building activities.

Deliverable 3.1.Planned training activities tailored to the identified gaps and needs in selected countries.

Deliverable 3.2. Regional and country training PV workshops as support to the implementation of institutional development plans.

Deliverable 3.3. Training materials

Output 4: Partnership and stakeholder coordination, participation to technical meetings with EMT, VDI and other relevant Offices in WHO and external partners.

Deliverable 4.1. Meeting planning documents and reports

METHODS TO CARRY OUT THE ACTIVITY

The contractual partner will work with EMT mainly and closely coordinating with Vaccine-Preventable Diseases and Immunization team to carry out the outputs and deliverables.

QUALIFICATIONS & EXPERIENCE

EDUCATION

Essential: Advanced level university (Masters level of above) in pharmaceutical sciences public health or relevant health-related field.

Desirable: Post-graduate degree in Regulatory Sciences

EXPERIENCE

Essential: Minimum ten years of experience in pharmacovigilance and/or pharmacoepidemiology. Demonstrated experience in government service, strong knowledge about Uppsala Monitoring Centre activities on pharmacovigilance.  

Desired: Experience in writing; previous work experience with government, WHO and UN organizations.

TECHNICAL SKILLS & KNOWLEDGE

In-depth knowledge on pharmacovigilance, high level skills in (a) strategic planning and execution strategy (b) collaboration with internal/external partner (c) ability to synthesize knowledge and effectively express ideas in writing (d) effective working relations with multidisciplinary and multicultural teams.

LANGUAGES

Written and spoken fluency in English is essential.

COMPETENCIES

• • Communicating in a credible and effective way
• • Producing results
• • Moving forward in a changing environment
• • Fostering integration and teamwork
• • Knowing and managing yourself
• • Ensuring Effective Use of Resources

ADDITIONAL INFORMATION

• • The contractor will work in close collaboration with DHS/EMT
• • The work will be done remotely or in countries depending on the COVID-19 pandemic situation
• • Duration of contract is from 15 October 2021 until 14 September 2022

APPLICATIONS

Qualified and interested specialists should submit their CV and cover letter with proposal to the Supply Officer through WP RO UNGM at < wproungm@who.int > by 20 September 2021

The cover letter should outline how their experience and qualifications make them a suitable candidate for this position and should include their proposed fee and availability.

Please use Tender Notice No. 141206 as subject to all submission. Only successful candidates will be contacted.