Consultant – Drug Safety Physician (Part-Time 50%) | DNDi | Deadline: 13 July 2026

The Drugs for Neglected Diseases initiative (DNDi) is recruiting a Consultant, Drug Safety Physician to support its global clinical development and pharmacovigilance activities. This part-time consultancy (50%) offers a unique opportunity to contribute to the development of safe, effective treatments for neglected diseases affecting vulnerable populations worldwide.

The role sits within DNDi’s Research and Development Department, which advances innovative treatments from early discovery through to patient access, with a strong emphasis on safety, regulatory compliance, and global health impact.

About DNDi and Its Mission

DNDi is an international non-profit organization dedicated to developing new treatments for neglected diseases that disproportionately affect low-income and underserved populations.

Its R&D department brings together:

• Disease expert teams (NTDs, viral diseases, and more)
• Clinical development sciences
• Regulatory sciences
• Pharmacovigilance and drug safety units
• Clinical operations and translational research teams

Together, these teams ensure that new treatments move safely and efficiently from laboratory research to patient care.

Role Overview

The Consultant, Drug Safety Physician will provide specialized expertise in clinical trial safety and pharmacovigilance, ensuring that DNDi’s clinical development programs meet the highest standards of safety and regulatory compliance.

This is a part-time consultancy (50%), based remotely across Africa, Europe, or Latin America.

Key Responsibilities

1. Clinical Trial Safety Review

The consultant will support the evaluation of clinical trial documentation and safety data, including:

• Reviewing protocols, investigator brochures, and informed consent forms
• Analyzing adverse events, laboratory data, and vital signs
• Contributing to updates of risk management plans
• Supporting safety oversight across clinical development programs

2. Signal Detection and Risk Management

A key part of the role involves identifying and managing emerging safety signals:

• Leading product safety management activities
• Supporting signal detection, evaluation, and validation
• Conducting aggregate safety data reviews
• Ensuring proper documentation and tracking of safety assessments

3. Regulatory Reporting and Compliance

The consultant will ensure compliance with global pharmacovigilance regulations:

• Reviewing and contributing to Individual Case Safety Reports (ICSRs)
• Preparing aggregate safety reports
• Supporting regulatory submissions and documentation
• Collaborating with internal and external oversight committees

4. Pharmacovigilance Systems and Capacity Building

The role also includes strengthening safety systems and knowledge-sharing:

• Keeping up to date with global pharmacovigilance guidelines
• Supporting audits and inspections
• Participating in capacity-building activities
• Contributing to training and guidance for clinical teams

Reporting and Collaboration

The consultant will report directly to the:

• Head of Drug Safety and Pharmacovigilance

They will collaborate with:

• Clinical development and safety teams
• Regulatory affairs professionals
• External research and partner organizations
• Internal safety and review committees

This is a highly collaborative role requiring cross-functional engagement.

Required Qualifications and Experience

Candidates must bring strong clinical and pharmacovigilance expertise, including:

• Medical Doctor (MD) qualification
• At least 12 years of professional experience, including 2–5 years in pharmacovigilance (industry experience preferred)
• Strong understanding of clinical development processes
• Experience in safety data analysis and risk management
• Familiarity with regulatory frameworks and global pharmacovigilance standards
• Proficiency in safety databases and coding tools such as MedDRA and WHOART
• Strong communication and organizational skills

Skills and Competencies

The ideal candidate should demonstrate:

• High level of initiative and independent working ability
• Strong analytical and problem-solving skills
• Ability to manage multiple priorities in a fast-paced environment
• Excellent written and verbal communication skills
• Experience working in cross-functional and international teams
• Strong computer literacy (MS Office and pharmacovigilance systems)

Preferred Experience

Additional advantages include:

• Experience in pharmaceutical industry regulatory interactions
• Familiarity with neglected disease clinical trials and LMIC settings
• Knowledge of aggregate safety reporting methodologies
• Experience supporting audits or regulatory inspections

Working Context

This consultancy is designed for experienced medical professionals who want to contribute to global health equity by ensuring safe and effective treatment development for neglected diseases.

The role is flexible and remote, allowing engagement from multiple regions including Africa, Europe, and Latin America.

How to Apply

Interested candidates should apply through the official DNDi careers portal:

CLICK HERE TO APPLY

Why This Role Matters

Drug safety is a critical component of clinical development, especially in neglected disease research where patients often have limited treatment options and higher vulnerability.

This role contributes directly to:

• Safer clinical trials
• Improved regulatory compliance
• Better risk management in drug development
• Faster and more reliable access to life-saving treatments
• Strengthening global pharmacovigilance systems

Final Reflection

The Consultant Drug Safety Physician role at DNDi is a highly specialized opportunity for senior medical professionals seeking to apply their expertise to global health challenges. It combines clinical insight, regulatory knowledge, and pharmacovigilance leadership in a mission-driven environment focused on addressing neglected diseases.

For experienced physicians with a strong background in drug safety, this consultancy offers both technical depth and meaningful impact in global health innovation.

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