International Consultant- Pharmacovigilance Systems Strengthening

1. Objectives

The overall objective of engaging a consultant is to accelerate implementation of PV IDPs to attain ML3 for vigilance functions.

Specific Objectives

1. To conduct a comprehensive baseline GBT assessment, assist in review of guidelines, SOPs, assessment tools, GBT evidence and provide guidance essential for fulfilling the identified IDPs.

2. Integrate GBT IDP implementation to promote compliance by industry, public health entities and national regulatory requirements.

2. Scope of Work

Output 1.1: Conduct a detailed landscape and SWOT analysis of vigilance systems within the BoMRA and related stakeholders in Botswana.

Output 1.2: Review guidelines, Standard Operating Procedures (SOPs) working tools, and regulatory actions and decisions aligned with WHO Global benchmarking standards.

Output 1.3: Provide review of

- Evaluation of Risk Management Planning (RMP) and related documents

- Safety Communication and Vigilance data Publication

- Vigilance documents during conduct of Good Vigilance Inspections

- Implementation of IDPs at Adverse Drug Reaction Monitoring Centres (AMCs) against the Field Visit Manual for Assessing the Performance of Vigilance Function

Output 1.4: Provide guidance on communication to BoMRA stakeholders on

- Activities to be conducted to enhance understanding and compliance to regulations and guidelines

3. Deliverables:

· Monthly Progress Reports - Monthly written reports summarizing:

· Activities conducted Progress against IDP milestones

· Challenges encountered and mitigation actions

· Recommendations for the next period

· Comprehensive end of activity report on vigilance systems within the BoMRA and stakeholders, including activities conducted and recommendations on how to strengthen existing systems.

· GBT implementation status >95% completion by March 2027.

· Review of training materials, including presentations, handouts, and session summaries for safety surveillance and causality assessment.

· Recommendations for sustaining and accelerating progress