Diego Mpia Elenge
Physician Scientist
Woluwe Saint Lambert,Brussels
Summary
Medical Doctor and Public Health Vaccinologist with 16 years of experience in clinical medicine, clinical trials, pharmacovigilance, and risk-benefit assessment. Proven expertise in global drug safety, signal management, regulatory compliance, and medical-scientific strategy. Adept at leading crossfunctional teams, collaborating with regulatory authorities, and ensuring the highest standards in safety governance. Fluent in English and French with strong analytical, communication, and leadership skills.
Overview
16
16
years of professional experience
Work History
Associate Medical Director, Safety Evaluation & Risk Management
GSK
Wavre
07.2022 - Current
- Lead global pharmacovigilance and safety signal management strategies for assigned products.
- Perform benefit-risk assessments and aggregate safety data reviews, ensuring compliance with regulatory requirements.
- Drive cross-functional collaboration with Regulatory Affairs, Clinical Development, and Medical Affairs to align safety communications and strategies.
- Prepare and review safety sections of clinical and regulatory documents, including study protocols, IBs, CSRs, and ICFs.
- Lead periodic safety report preparation (PSURs, DSURs) and safety submissions for global regulatory agencies.
- Provide safety leadership for Data Safety Monitoring Boards (DSMBs) and internal safety governance.
- Oversee medical assessments of individual case safety reports (ICSRs) and ensure timely reporting of SUSARs and urgent safety issues.
Senior Manager Safety Physician, Safety Evaluation & Risk Management
GSK
Wavre
11.2018 - 06.2022
- Led safety signal management activities, including literature reviews, ICSRs, and aggregate data reviews.
- Chaired Safety Review Team (SRT) meetings, leading discussions on benefit-risk evaluations.
- Authored and reviewed key safety documents, including PSURs, DSURs, RMPs, and regulatory responses.
- Provided medical oversight for safety sections in clinical trial documentation (protocols, CSRs, IBs, and ICFs).
- Led safety discussions with regulatory agencies and participated in IDMC/DSMB meetings.
Vaccines Medical Affairs Manager, Central Africa Region
GSK
Kinshasa
12.2015 - 02.2018
- Provided medical and scientific leadership in vaccine safety and risk management.
- Engaged with Key Opinion Leaders (KOLs) and healthcare professionals to support vaccine education and advocacy.
- Managed regional pharmacovigilance strategies, strengthening regulatory compliance in Central Africa.
Chief Executive Officer & Co-Founder
GoResearch CRO
Kinshasa
01.2018 - 12.2018
Senior Vaccinologist
University of Kinshasa & Agence de Médecine Préventive
01.2014 - 12.2015
Cluster Physician (Intern)
Novartis
Siena
01.2013 - 12.2014
Medical Officer
Medics Clinics
Kinshasa
01.2010 - 12.2013
Education
Executive Master - Vaccinology & Pharmaceutical Clinical Development
University of Siena & Novartis Vaccines Academy
01.2014
Doctor of Medicine - undefined
University of Kinshasa
01.2010
Skills
- Pharmacovigilance
- Drug Safety
- Safety signal detection
- Risk-benefit assessment
- Safety governance
- Regulatory Compliance
- Risk Management
- Global safety submissions
- Risk management plans
- Periodic safety reports
- Medical Safety Leadership
- Oversight of safety sections
- Safety communication strategies
- Cross-functional collaboration
- Stakeholder Engagement
- Team Leadership
- Collaboration with internal stakeholders
- Collaboration with external stakeholders
- Scientific Communication
- Safety Communication
- Authoring safety deliverables
- Clinical study protocols
- Regulatory documents
Certification
Certification in ICH-GCP (Good Clinical Practices), Royal College of Physicians
Affiliations
- Brighton Collaboration Foundation
- Global Leaders Network
Languages Skills
French (native), English (fluent), MedDRA, Argus, EDC, SPSS, Microsoft Office Suite, Veeva CRM, Spotfire
Credentials
- MD
- MSc
Publications
Multiple peer-reviewed articles on vaccine safety and pharmacovigilance., GSK Africa & DC Top 150 Leaders (2017), Global Recognition-Golden Award (2017), Novartis Vaccines Scholar (2013)
Timeline
Associate Medical Director, Safety Evaluation & Risk Management
GSK
07.2022 - Current
Senior Manager Safety Physician, Safety Evaluation & Risk Management
GSK
11.2018 - 06.2022
Chief Executive Officer & Co-Founder
GoResearch CRO
01.2018 - 12.2018
Vaccines Medical Affairs Manager, Central Africa Region
GSK
12.2015 - 02.2018
Senior Vaccinologist
University of Kinshasa & Agence de Médecine Préventive
01.2014 - 12.2015
Cluster Physician (Intern)
Novartis
01.2013 - 12.2014
Medical Officer
Medics Clinics
01.2010 - 12.2013
Executive Master - Vaccinology & Pharmaceutical Clinical Development
University of Siena & Novartis Vaccines Academy
Doctor of Medicine - undefined
University of Kinshasa