CONSULTANT, DRUG SAFETY PHYSICIAN

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.