CONSULTANT, DRUG SAFETY PHYSICIAN

• →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

• Head of Drug Safety and Pharmacovigilance

• Clinical and safety team members
• Partner organizations within the clinical development program
• Internal and external committees reviewing safety data

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

• Physician, MD

• 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

• 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.