Medical Reviewer

Job DescriptionProvides medical expertise in the review and evaluation of safety information for investigational and marketed products, including evaluation of serious clinical trial adverse events and spontaneous reports of adverse eventsAssesses the relationship between drugs and adverse eventsEvaluates case reportability per local regulatory requirements and meets appropriate timelines for case reviewParticipates in the training of the Safety Specialist and CoordinatorsEssential Functions:Responsibilities Percent of TimeMedical Review of Individual Safety Case ReportsParticipates in the training of the Safety Specialists and CoordinatorsAdministration, Education and miscellaneousScope MeasuresCollaborates with sub-group of health care professionals responsible for an aspect of case processing with emphasis on timely Medical Review and appropriate distribution and submission of case of cases to affiliates, partners and Regulatory AuthoritiesResponsible for the Causality Assessment for both, developmental and marketed product safety for Individual Case Safety ReportsKnowledgeSkillsAbilities RequiredHealth care professional degree required - MDOver 5 years previous experience in Medical reviewKnowledge of disease pathology and physiology, pharmacology and therapeuticsKnowledge of International and US Regulatory RequirementsAbility to work effectively in high paced and team environment.Strong organizational, written and verbal communication skillsPrevious experience using a Pharmacovigilance DatabaseExperience with quality assurance activities; attention to detail

Created: 2024-11-09