[Hiring] CONSULTANT, DRUG SAFETY PHYSICIAN @Drugs for Neglected Diseases initiative

Role Description

Consultant, Drug Safety Physician in clinical development (Part time (50%) – Consultancy

• 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

• 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

• 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

• Understanding global pharmacovigilance regulations and guidelines and keeping up to date
• Participating in capacity building
• Supporting audits and inspections as requested

Qualifications

• 12 years overall professional experience including 2 to 5 years of PV experience (including some in industry)
• Physician, MD

Requirements

• 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
• Fluent in English
• Good knowledge of MS Office, MedDRA, WHOART, working knowledge of safety databases

Company Description