Medical Safety Expert

The Opportunity This position works out of our Bogota location in the Established Pharmaceuticals division.We are committed to bringing the benefits of our trusted medicines to more people in the world's fastest-growing countries.Our broad portfolio of high-quality and differentiated branded generic medicines reaches across multiple therapeutic areas including gastroenterology, women's health, cardiometabolic, pain management/central nervous system, and respiratory.As the Medical Safety Expert is to provide guidance, direction and expertise for pharmacovigilance activities within one`s responsibility.What You'll Do :Performs Health Hazard Assessments and Quality Related Medical Expert StatementsRepresents Abbott towards governmental agencies and other competent authorities related to Pharmacovigilance topicsDevelops strategic risk management plans for assigned productsReviews clinical study protocols, their reports and publicationsProactively understands regulatory framework, trends & requirements related to products and clinical studiesProvides safety expertise throughout all stages of global drug developmentDevelops and reviews safety information as part of reports submitted to regulatory authoritiesIs accountable for the safety monitoring strategy (including ICSR, aggregate data and literature review) and reference safety information documents throughout a product's lifecycle, thereby minimizing patient and product risk.Performs Medical assessment during processing of solicited casesRequired QualificationsDoctor of Medicine (MD), experienced in Infectiology/MicrobiologyExperience with BiosimilarsPreferred QualificationsMinimum 3-5 years industry experience in Pharmacovigilance, Medical Affairs of Clinical DevelopmentFluent in EnglishBroad and proficient understanding and experience in Pharmacovigilance in the pharmaceutical industry or academia or equivalentExperienced professional operating within the international arena or working across functional areas