CONSULTANT, DRUG SAFETY PHYSICIAN

• Review clinical trial documents and lead analysis of safety data (adverse events, lab data, vital signs) to update risk management plans.
• Lead the Product Safety Management Team, perform signal detection and evaluation, and ensure documentation of safety assessments.
• Contribute to regulatory reporting (ICSRs, aggregate reports) and collaborate with internal/external committees on safety profile and risk management.
• Stay updated on global pharmacovigilance regulations, participate in capacity building, and support audits/inspections.

This role directly contributes to the development of safe and effective treatments for neglected diseases, ensuring patient safety and enabling access to new therapies for underserved populations worldwide.

• Physician (MD) with 12+ years overall professional experience including 2-5 years of pharmacovigilance experience in industry.
• Excellent knowledge of clinical development process and ability to manage competing tasks in a fast-paced environment.
• Proficiency in MS Office, MedDRA, WHOART, and working knowledge of safety databases.
• Fluent in English; experience with regulatory interactions and neglected disease populations is advantageous.

Part-time (50%) consultancy position with flexible location (Africa, Europe, Latam). Compensation details not specified.

Drugs for Neglected Diseases initiative (DNDi) is a nonprofit research and development organization that drives therapeutic innovation from lab bench to patient bedside, advancing treatment candidates for neglected diseases.