Drug Safety Officer (Maternity Cover 2 Years) - 230001BQ
Applicants are required to read, write, and speak the following languages: English
Preferred 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.
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. Cerner Enviza is immersed in all of these, and there has never been a better time to join us and make a difference to our clients and the lives of patients.
Job Description
Cerner Enviza is looking for a Two Year Maternity Cover 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, reconciliation, and supporting the creation of annual safety reports, e.g., Development Safety Update Reports.
Detailed Description and Job Requirements
Responsible for conducting applied research in the 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.
This is an entry-level position for those who are new to consulting and are developing their expertise. The candidate will receive detailed instruction on routine work and will be responsible for performing basic experiments and tests on research topics and documenting results. As a member of a project team, the candidate will follow standard practices and procedures to evaluate and analyze data, develop reports and presentations in external customer engagements. The candidate will use available tools to analyze and solve problems for clients and may perform other duties as assigned.
Minimum Qualifications:
Bachelor's or Advanced degree in a discipline relevant to the area of focus, plus 1 year related work experience.
At least 4 years total combined related work experience and completed higher education.
Job: Consulting
Location: ES-ES, Spain - Madrid
Job Type: Temporary Employee Hire
Organization: Oracle
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