Drug Safety Officer - 2300043GLanguages Required: English, SpanishPreferred Qualifications: Cerner Enviza, an Oracle company, is a leading global healthcare consulting firm and trusted advisor to many of the world's top pharmaceutical, biotech, and medical device & diagnostic companies. By supporting the work of Cerner Enviza, you will work with world-class healthcare companies, helping them improve global access to medicines by connecting science and research. Cerner Enviza is passionate about our people, our business, and our clients and is proud to foster a culture that contributes to the health and well-being of humankind. Leading through innovation, we consistently challenge ourselves to discover and embrace new and creative ways to deliver exceptional insight for clients.Responsibilities:Support the creation, maintenance, and implementation of study-specific documents (e.g., Safety Management Plans).Responsible for the creation and maintenance of the Pharmacovigilance Master File and case files.Track and process adverse events and other safety relevant information from clinical trials and non-interventional studies (NIS) in consideration of applicable timelines, including writing of narratives, coding, and reconciliation.Support the creation of annual safety reports, e.g., Development Safety Update Reports.Screen CRF data for (serious) adverse events and other safety-related information.Assist in the preparation of Safety Screening Specifications.Perform case processing of (serious) adverse events and other safety events, including data entry of safety data in the safety database and coding of safety data (MedDRA, WHO-DD).Create safety narratives for non-interventional and clinical studies.Identify and classify safety events.Review, analyze, and validate (serious) adverse events and other safety data for completeness, consistency, integrity, and accuracy.Create regular safety status reports (e.g., line listings).Perform and manage (S)AE reconciliation.Support Medical Writing in the preparation of periodic safety reports, e.g., DSUR.Develop relationships with clients and act as a junior point of contact for project requests/questions.Prioritize workload to ensure agreed deadlines are met.Education: Master's degree and 2-3 years relevant practical experience, or a bachelor's degree and a minimum of 2-3 years of practical experience, or relevant professional education and a minimum of 4 years of practical experience or equivalent.General Experience & Knowledge:Highly articulate.Sound numerical reasoning.Highly analytical with a problem-solving approach.Careful, precise work.Highly service-oriented.Team player.Good knowledge of MS Office and IT.Very good command of spoken and written Spanish and English.Role-related Experience, Knowledge & Skills:First drug safety experience, preferably within a CRO environment.Ability to self-organize and multitask.Solid analytical skills.A good understanding of the healthcare and pharmaceutical sector.Basic client management skills.Detailed Description and Job Requirements:Responsible for conducting applied research in the scientific area of focus, investigating applicable solutions through rigorous studies, and ensuring that a quality, integrated solution is delivered in a timely manner, at budget, and to our client's satisfaction. This involves working closely with the client to understand and manage their expectations, as well as working closely with Oracle and third-party vendors to ensure delivery. Entry-level position for those who are new to consulting and are developing their expertise. Receives detailed instruction on routine work and is responsible for performing basic experiments and tests on research topics and documenting results. As a member of a project team, follows standard practices and procedures to evaluate and analyze data, develop reports.
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