Overview
The Consultant 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.
Key Responsibilities
- Conduct landscape analysis to assess uptake and implementation of the WHO Smart Pharmacovigilance Strategy.
- Facilitate regional uptake of normative guidance and technical tools for Smart Pharmacovigilance.
- Assist countries in addressing and implementing WHO Global Benchmarking Tool (GBT) Vigilance (VL) indicator-related actions.
- Support strengthening integration of PV within immunization programmes and other public health programmes.
- Support the regional roll-out of the WHO Model Risk Management Plan (RMP) Assessment Tools.
- Support planning and facilitation of a regional workshop and/or virtual training activities on RMP assessment, risk-based pharmacovigilance and regulatory risk communication.
- Support preparation for implementation of drug utilization study on sodium valproate in a selected country.
Required Experience
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 LMICs at national and international level.
Qualifications
Advanced degree (A Master’s degree or higher) in pharmacy, chemistry, biochemistry, microbiology, or a related health or life sciences field from a recognized university.
