Job Title

Key Roles and Activities : Senior Surveillance Scientist:The Senior Surveillance Scientist will support the Signal Tracking Team and safety and quality systems, by performing activities such as, but not limited to:Attention to detail and ability to analyze data in a broader contextAbility to understand the nature of adverse drug reactions and complex associationsAbility to perform aggregate safety analysis and case level review.Performance of ad hoc data mining activities in external safety databases (e.g., FAERS, VigiBase, EudraVigilance) utilizing Empirica Signal and EudraVigilance data analysis system (EVDAS).Performance of safety data assessment through the review, analysis, interpretation, and summary of case and aggregate safety data from various sources such as clinical, post-marketing, observational studies, medical literature, health authority databases, and product quality databases.Identification and validation assessment of safety signalsAct as SMT member and provide SMT presentations as supportQualification & Experience Requirements:A minimum of two years of post-marketing safety and/or epidemiology experience; five years of relevant experience is preferredAdvanced degree (e.g., MD, MPH, PharmD) in life sciences or health-care discipline preferredDegree (e.g., B.S., B.S.N.) in life sciences or health-care disciplineKnowledge of principles of drug safety, specifically case series analysisBasic understanding of industry regulations and compliance needs; knowledge of GVP Module IX preferred.Expert-level ability to search, analyze, interpret, and clearly present safety, scientific, and clinical data in written formatExperience authoring complex aggregate safety reports and assessmentsAdvanced-level skills in MS Outlook, Word, and Excel and Adobe AcrobatExcellent verbal and written communication skills; Strong English verbal and written communication skillsMeticulous attention to detail and thorough completion of complicated tasksExpertise in pharmacology, epidemiology, biostatistics, and/or decision sciences preferredExpert-level skills in MS Excel and data manipulation in ExcelExperience using GxP IT Systems; experience with Empirica signal platform preferredMust be strong independent worker and team player