Kefentse Malefo
Johannesburg
Summary
Accomplished Pharmacovigilance Specialist with extensive experience at Roche Pharmaceuticals and AbbVie, specializing in drug safety monitoring and effective stakeholder communication. Proven success in enhancing patient safety and compliance through strategic project management and a commitment to continuous improvement. Demonstrated ability to implement quality standards and drive significant advancements in pharmacovigilance practices.
Overview
7
7
years of professional experience
Work History
South Africa-Dubai Quality & Compliance Partner (SA Location)
Roche Pharmaceuticals
Johannesburg
05.2024 - Current
- Assisted Hub Quality Champion in managing CSFM processes and quality deliverables.
- Collaborated with stakeholders to develop root cause analysis and corrective action plans.
- Collaboration is always with the Affiliate Quality Responsible on all PV Hub-APS interface PV activities, when required
- Generating, reviewing and quality checks of PV Hub compliance monitoring report for oversight of quality and compliance by the Hub team
PV Specialist/ PV Hub Partner
Roche Pharmaceuticals
Johannesburg
10.2019 - Current
- Collect, report and handle safety information related to Roche products in compliance with global and local standards.
- Study and program oversight
- Supported LSR in the local adaptation of ARMMs before submission to health authorities.
- Provided critical support to LSR for maintaining oversight of PV tasks defined in agreements.
- Maintained a robust PV quality system adhering to both global and local regulatory mandates.
- Regularly updated necessary databases to ensure data integrity.
- Supports the PV-hub department in ensuring high standards are maintained and opportunities for departmental improvements are identified and implemented
- Guides PV Associates during daily activities
DiCELA Audit
Roche Pharmaceuticals
Johannesburg
01.2024 - 01.2024
- Facilitated audit participation for the MCSA Affiliate by representing the Hub team in Digital Customer Engagement reviews.
- I was able to demonstrate that for all the DiCELA within the audit review period, case transmission verification and contact testing were performed timely or where performed late, deviations were raised and actioned appropriately
- Impact: This resulted in three positive affirmations and no findings due to the Hub team
Africa Safety Cluster Meeting
Roche Pharmaceuticals
Johannesburg
01.2024 - 01.2024
- Facilitated face-to-face interaction between Africa Safety Cluster and Regional LSRs.
- Collected topics, drafted agendas, and concluded plans for three-day meetings.
- Managed logistics such as organizing facilities and coordinating transfer schedules.
- Enhanced team connection to support patient safety needs.
- Stronger and earlier collaboration to eliminate duplication of efforts
South Africa PV Hub Quality Champion
Roche Pharmaceuticals
Johannesburg
08.2021 - 05.2023
- Served as representative of SA PV Hub team in the Pan Hub Quality network.
- Streamlined processes to uphold high-quality standards across PV Hub activities.
- Responsibilities included supporting the team with RCA and CAPA management and overall support in driving the implementation of QMS in the Hub
DiCELA Transition
Roche Pharmaceuticals
Johannesburg
11.2021 - 02.2022
- Implemented a new SOP to guide the process of handling patient safety events through digital channels.
- Provided recommendations to enhance procedural compliance and efficiency.
- Provided the team with go-live readiness by ensuring that they were well-trained and obtained access to the new system in readiness of the go-live launch
Pharmacovigilance Associate
AbbVie
Johannesburg
08.2018 - 10.2019
- Managed the reporting of adverse events.
- Analyzed and addressed product-related complaints to enhance customer satisfaction.
- Optimized SOPs to enhance operational performance.
- SDEA and other agreements
- Internal/External contacts and interactions
- Reporting of serious cases to local regulatory authority
Education
Bachelor of Clinical Medical Practice -
University of Witwatersrand
South Africa12.2017
BSc - Human Physiology
University of Pretoria
South Africa12.2012
Skills
- Pharmacovigilance Expertise
- Risk Management Planning
- Case processing
- Pharmacovigilance compliance
- Adverse event reporting
- Standard operating procedures
- Stakeholder communication
- Drug safety monitoring
- Pharmacovigilance training
- CAPA management
- Patient safety assessment
- Root Cause Analysis Management
- Submissions
- Quality
- Analytical Problem Solving
- Strategic thinking
- Agility
- Growth Mindset
- Effective Coordination
- Project Management
- Time management
- Stakeholder management
- Post-marketing surveillance
- Regulatory submissions
- Fluent in english
- Good pharmacovigilance practice
References
Available on request
Projects
2ND EU PV Hub: Capability building, 01/01/23, 05/31/23, The project was aimed to support the new Germany Hub from a perspective of the PV Hub community, focusing on capability building and PV Operations. Russia PV Hub Transition (Co-Lead), 07/01/24, 09/30/24, Onboarding, process and country transition of activities to support three Eastern Europe Affiliates.
Languages
- English
- Setswana
Professionalsocieties
Health Professions Council of South Africa, Clinical Associate, 12/01/17
Languages
SETSWANA
First Language
English
Advanced (C1)
C1
References
References available upon request.
Timeline
South Africa-Dubai Quality & Compliance Partner (SA Location)
Roche Pharmaceuticals
05.2024 - Current
DiCELA Audit
Roche Pharmaceuticals
01.2024 - 01.2024
Africa Safety Cluster Meeting
Roche Pharmaceuticals
01.2024 - 01.2024
DiCELA Transition
Roche Pharmaceuticals
11.2021 - 02.2022
South Africa PV Hub Quality Champion
Roche Pharmaceuticals
08.2021 - 05.2023
PV Specialist/ PV Hub Partner
Roche Pharmaceuticals
10.2019 - Current
Pharmacovigilance Associate
AbbVie
08.2018 - 10.2019
Bachelor of Clinical Medical Practice -
University of Witwatersrand
BSc - Human Physiology
University of Pretoria