A Clinical Safety Specialist is responsible for the overall safety and oversight of clinical studies. The job requires working with other members of the safety team, such as data management, clinical operations, and regulatory affairs. These collaborations are needed to manage adverse events reporting.
The Clinical Safety Specialist is the intermediary for safety related questions from the study team, field personnel, and the study sites. He or she writes clinical safety plans which are used for assigned protocols. For the development of case report forms and safety reports, Clinical Safety Specialists collaborate with the data management department and other departments. Data management is an important skill to have as a Clinical Safety Specialist, since data management is often conducted in the clinical safety database. The Clinical Safety Specialist assists with writing the safety section of clinical protocols and is present at safety monitoring meetings. To obtain additional information, the Clinical Safety Specialist interacts with investigational sites and field monitors. To ensure consistency in assessing and monitoring clinical safety events, the Clinical Safety Specialist collaborates with the clinical project team. Lastly, the Clinical Safety Specialist has the responsibility of assessing whether adverse events need to be reported.
The requirements for this position are dependent on the type of company and clinical studies that are executed. These different types of activities and companies require different knowledge and experiences. In general, there are basic requirements and skills needed:
Vacancies for Clinical Safety Specialists regularly come available at QTC Recruitment. The available vacancies exclusively belong to QTC Recruitment’s employers. If you are interested in this position, or any other related position, you can send your resume to firstname.lastname@example.org or feel free to contact us at +31 (0)23 754 86 60.