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About the Role

DNDi's Research and Development Department drives therapeutic innovation from the lab bench to the patient bedside, advancing DNDi’s portfolio of treatment candidates from design to patient access. This role supports clinical and safety team members with safety and risk management expertise, leads the Product Safety Management Team, and contributes to regulatory reporting requirements.

Responsibilities

• Reviewing clinical trial documents, including protocols, statistical analysis plans, informed consent forms, investigator brochures, and briefing documents.
• Leading the analysis and review of clinical trial safety data, including adverse events, laboratory data, and vital signs, and updating the development risk management plan.
• Supporting clinical and safety team members with safety and risk management expertise.
• Leading the Product Safety Management Team.
• Supporting signal detection, evaluation, and validation, and completing aggregate safety data reviews for safety signals.
• Ensuring adequate documentation, communication, and tracking of safety data assessments.
• Contributing to regulatory reporting requirements, such as Individual Case Safety Report review and Aggregate Safety reports.
• Collaborating with internal and external committees regarding the assessment of the evolving safety profile and risk management.
• Understanding global pharmacovigilance regulations and guidelines and staying current.
• Participating in capacity building.
• Supporting audits and inspections as requested.

Requirements

• 12 years overall professional experience.
• 2 to 5 years of PV experience, including some in industry.
• Experience in the pharmaceutical industry and interactions with regulatory authorities is advantageous.
• Knowledge of commonly used methods for summarizing aggregate safety data.
• Understanding of the challenges of conducting clinical trials in populations living with neglected diseases is welcome.

Skills

• Excellent knowledge of the clinical development process.
• High level of initiative and independence.
• Excellent written and verbal communication skills.
• Resourcefulness and personal organization skills.
• Demonstrated cross-functional teamwork.
• Ability to guide clinical and DS & PV team members.
• Ability to manage competing tasks and deadlines in a fast-paced environment.
• Computer literacy with proficiency in MS Office, MedDRA, and WHOART.
• Good knowledge of MS Office, MedDRA, WHOART.
• Working knowledge of safety databases.
• Fluent in English.

Location

• Africa
• Europe
• Latam

Work Type

• Part time (50%)
• Consultancy

Experience Level

• 12 years overall professional experience
• 2 to 5 years of PV experience

Education Level

• Physician, MD

About the Company

• The Research and Development Department includes three clusters of disease expert teams: NTD: Mycetoma and Leishmaniasis; NTD: Chagas, Filarial, and HAT; and Viral Diseases.
• Integrated Clinical Development Sciences (Drug Safety & Pharmacovigilance, Clinical Quality Assurance, and Translational Sciences), Regulatory Sciences, Clinical Operations, Discovery, and Pharmaceutical Development teams complement DNDi’s R&D expertise.