About the Department
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. The department drives therapeutic innovation from the lab bench to the patient bedside, advancing DNDi’s portfolio of treatment candidates from the outset (with the design of target product profiles) to the end point (enabling patients’ access to new treatments).”
About the Office
Based anywhere in Africa, Europe and Latam
Overview
Consultant, Drug Safety Physician in clinical development (Part time (50%) – Consultancy)
Responsibilities
1st area
- Reviewing clinical trial documents (e.g., protocol, statistical analysis plan, informed consent form, investigator brochure, briefing documents)
- Leading the analysis and review of clinical trial safety data (adverse events, laboratory data and vital signs) and updating the development risk management plan as needed
- Supporting clinical and safety team members with safety and risk management expertise
2nd area
- Leading the Product Safety Management Team
- Supporting signal detection, evaluation, and validation and complete aggregate safety data reviews for safety signals
- Ensuring adequate documentation, communication and tracking of safety data assessments
3rd area
- Contributing to regulatory reporting requirements (e.g., Individual Case Safety Report review, Aggregate Safety reports)
- Collaborating with internal and external committees with regards to the assessment of the evolving safety profile and risk management
4th area
- Understanding global pharmacovigilance regulations and guidelines and keeping up to date
- Participating in capacity building
- Supporting audits and inspections as requested
Reporting line & Interactions
Reporting line
- Head of Drug Safety and Pharmacovigilance
Interactions
- Clinical and safety team members
- Partner organizations within the clinical development program
- Internal and external committees reviewing safety data
Experience and Education
Experience
- 12 years overall professional experience including 2 to 5 years of PV experience (including some in industry)
Education
- Physician, MD
Skills and competencies
Skills and Attributes
- Excellent knowledge of clinical development process
- High level of initiative and independence
- Excellent written and verbal communication skills, resourcefulness and personal organization skills together with demonstrated cross-functional team work and 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, WHOART
R& D Technical Skills
- Fluent in English
- Good knowledge of MS Office, MedDRA, WHOART, working knowledge of safety databases
Other requirements
- Experience in pharmaceutical industry and interactions with regulatory authorities would be advantageous
- Knowledge of commonly used methods for summarising aggregate safety data
- Understanding of the challenges of conducting clinical trials in populations living with neglected disease would be welcome
Please note that only shortlisted candidated will be contacted.
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