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

4.       Qualifications, experience, skills and languages

Qualifications

Advanced degree in pharmacy, public health, regulatory science, or related field

Experience

-       Essential:  Experience working in the medicine regulatory authority/agency and over 5 years of relevant work experience in pharmacovigilance, vaccine safety, benefit-risk aggregated report review and risk management planning with a focus on risk minimisation measures.

-       Desirable: Experience with WHO Global Benchmarking Tools and/or ICH/EMA guidelines.

Skills/Knowledge

-       Expert in the field of: pharmacovigilance, vaccine safety and medicine risk management review.

Languages and level required

-       Fluent in English (spoken and written).

5.       Technical Supervision

On a day-to-day basis, the consultant will report to:

·         Dr Parthasarathi Gurumurthy, Chief Regulatory Officer (Ag), Botswana Medicines Regulatory Authority, pgurumurthy@bomra.co.bw

·         Mr Lebogang Koitsiwe, Director Pharmacovigilance and Clinical Trials (Ag), Botswana Medicines Regulatory Authority, lkoitsiwe@bomra.co.bw

Overall contractual oversight will be provided by Dr. Fabian NDENZAKO, WHO Representative

6.       Location

On site: Botswana Medicines Regulatory Authority Head Office, Gaborone, Botswana

Off site: Audit/Inspection Visits to selected AMCs (e.g. Molepolole, Gaborone, Lobatse, Maun) selected Health Facilities, GVP MAH inspection site as per annual plan.

7.       Travel - If travel is involved, full medical clearance is required

The consultant is expected to travel to Gaborone, Botswana to conduct the assignment. All travel arrangements will be made by WHO. Travel within Botswana will be organized as per workplan

8.       Remuneration and budget

As per the WHO policy/guidelines. P4 level

9.       Proposed Timelines

Start date: 11^th January 2027

End date: 9^th April 2027

Total duration: 3 months

10.    Roles and Responsibilities

Consultant

-       Deliver agreed outputs

-       Maintain confidentiality

-       Develop GBT evidence review plan in collaboration with NRA

BoMRA

-       Provide access to documents, staff and facilities

-       Assign focal point

-       Facilitate meetings and logistics

-       Review GBT evidence review plan in collaboration with consultant