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.

With ongoing and ground-breaking developments in Oncology and Rare Disease, an increased focus on more scientific, targeted medicine and continuous integration of technology into development and delivery of medicine,    there has never been a more exciting time to work in Life Sciences and, with Cerner Enviza immersed in all of these, there has never been a better time to join us and make a difference to our clients and the lives of patients.

Cerner Enviza are looking for a Drug Safety Officer. This role is a remote role to be based in Spain.

The Drug Safety Officer supports the creation, maintenance and implementation of study-specific documents (e.g. Safety Management Plans), and is responsible for the creation and maintenance of the Pharmacovigilance Master File and case files. They are responsible for the tracking and processing of 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 and supporting the creation of annual safety reports, e.g. Development Safety Update Reports.

The successful candidate should be degree qualified with a minimum of 2-3 years of practical experience. Drug safety experience, preferably within a CRO environment is highly desirable.

Responsible for conducting applied research in scientific area of focus. Investigating applicable solutions through rigorous, protracted 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 test on research topic and documenting results. As a member of a project team, follows standard practices and procedures to evaluate and analyze data, develop reports and presentations in external customer engagements. Uses available tools to analyze and solve problems for clients. May perform other duties as assigned.

Bachelors or Advanced degree in a discipline relevant to area of focus, plus 1 year related work experience. Minimum Qualifications: At least 4 years Total combined related work experience and completed higher education. Depending on the job there may be additional minimum requirements and/or preferred qualifications