Technical Officer – Pharmacovigilance

Volunteering

Overview

Support the implementation of the WHO Pharmacovigilance strategy in the region.

You have:

• At least five years of relevant experience in pharmacovigilance/regulatory science/medicines or vaccine safety, including experience with signal detection/assessment and safety communication; experience supporting national authorities or programmes in low- and middle-income countries (LMICs).
• Experience with reliance/work-sharing, Good Benchmarking Tool (GBT) benchmarking/Individual Development Plan (IDP) implementation, active surveillance, and interoperability projects; familiarity with Uppsala Monitoring Centre (UMC)/World Health Organization (WHO) tools (VigiFlow, VigiLyze, VigiMobile/MedSafety) and Medical Dictionary for Regulatory Activities (MedDRA)/WHO Drug Dictionary (WHODrug).
• Applied knowledge of pharmacovigilance (PV) methods across the product life cycle; adverse events of special interest (AESI) case definitions; causality assessment; Risk Management Plan (RMP)/Periodic Safety Update Report (PSUR)/Periodic Benefit-Risk Evaluation Report (PBRER) review; benefit–risk assessment.
• Practical understanding of risk-based prioritization, reliance/work-sharing models, and integration of pharmacovigilance in regulatory and public health systems.
• Excellent writing, facilitation, and stakeholder engagement skills; ability to develop guidance, standard operating procedures (SOPs) and training.

Contract

This is a UNV contract. More about UNV contracts.

Under the overall guidance of the Regional Adviser/Team Lead and in close collaboration with WHO headquarters (HQ), and country offices, the Technical Officer (Pharmacovigilance) will support Member States to implement the WHO Resolution on, and to operationalize the global smart pharmacovigilance strategy, including risk-based prioritization, reliance/work-sharing, integration in regulatory systems, and strengthened safety communication.

1. Facilitate regional uptake of global normative guidance and technical tools for smart pharmacovigilance and support measurement of uptake and impact of the global smart pharmacovigilance (PV) strategy (e.g., prioritized product lists, Adverse Events of Special Interest (AESI ) risk registers, reliance/work‑sharing, VigiBase use, PV maturity progress).

2. Support pharmacovigilance system assessments (e.g., World Health Organization (WHO) Global Benchmarking Tool – GBT) and assist countries in addressing and implementing PV components of Institutional Development Plans (IDPs).

3. Coordinate with WHO Collaborating Centres in the Region.

4. Support regional implementation of WHO-developed PV tools and protocols (e.g., reporting forms: VigiMobile, VigiFlow/VigiLyze, active surveillance protocol, background data on AESI, Risk Management Plan (RMP) assessment templates), particularly for the introduction of prequalified and new medicines/vaccines, and ensure relevant data are shared with WHO Headquarters (HQ ) advisory committees.

5. Provide feedback to WHO Headquarters (HQ ) on the feasibility and contextualization of global PV metrics; coordinate and support pilots in selected countries and scale‑up as it relates to the WHO Africa region.

6. Strengthen regional PV collaboration, including information‑sharing mechanisms, reliance and work‑sharing arrangements, and joint signal reviews with National Regulatory Authorities (NRAs ) and programmes.

7. Support countries in prioritizing risk‑based PV actions and strengthen collaboration of PV within immunization and public health programmes to reduce data silos, align case definitions, investigations, and risk communication.

8. Advocate for the Vaccine Safety Net (VSN) and promote trustworthy communication channels.

9. Represent the Region in Programme for International Drug Monitoring (PIDM ) forums (e.g., annual meeting) and support the organization of regional PIDM activities when hosted by a Member State.

10. Provide technical assistance to countries to detect and act on local signals and convene regional network meetings on priority topics.

11. Support countries to improve reporting and build capacity for causality assessment and data analysis for safety signals and reporting.

12. Advance the use of artificial intelligence (AI ) in pharmacovigilance in the region.

13. Conduct surveys and landscape analysis of the uptake of the Smart Strategy.

14. Provide support in coordinating and engaging relevant technical experts, as required, for the effective implementation of planned PV activities in the region

• Teamwork • Respecting and promoting individual and cultural differences • Communication • Producing results • Ensuring the effective use of resources

Experience • Essential: At least five years of relevant experience in pharmacovigilance/regulatory science/medicines or vaccine safety, including experience with signal detection/assessment and safety communication; experience supporting national authorities or programmes in low- and middle-income countries (LMICs). • Desirable: Experience with reliance/work-sharing, Good Benchmarking Tool (GBT) benchmarking/Individual Development Plan (IDP) implementation, active surveillance, and interoperability projects; familiarity with Uppsala Monitoring Centre (UMC)/World Health Organization (WHO) tools (VigiFlow, VigiLyze, VigiMobile/MedSafety) and Medical Dictionary for Regulatory Activities (MedDRA)/WHO Drug Dictionary (WHODrug).

Skills and knowledge • Applied knowledge of pharmacovigilance (PV) methods across the product life cycle; adverse events of special interest (AESI) case definitions; causality assessment; Risk Management Plan (RMP)/Periodic Safety Update Report (PSUR)/Periodic Benefit-Risk Evaluation Report (PBRER) review; benefit–risk assessment. • Practical understanding of risk-based prioritization, reliance/work-sharing models, and integration of pharmacovigilance in regulatory and public health systems. • Data skills: management, quality assurance, basic analytics/visualization; familiarity with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2B(R3) standards and data governance principles. • Excellent writing, facilitation, and stakeholder engagement skills; ability to develop guidance, standard operating procedures (SOPs) and training.

Brazzaville is a family duty station with access to basic services, medical facilities, and international travel connections. The environment is culturally rich but requires adaptability and resilience. You can check full entitlements at the duty station at https://app.unv.org/calculator. The complete UN Volunteer Conditions of Service is available at https://explore.unv.org/cos

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Potential interview questions

Added 8 days ago - Updated 3 hours ago - Source: unv.org