The Safety Specialist will provide technical and process-related expertise to drug safety management, ensuring compliance with relevant regulations as well as company procedures.
Responsibilities will include but not limited to tasks related to adverse event processing and reporting. Our professionals ensure accurate entry and coding of SAEs/AEs into the safety database and perform initial review of adverse events, seriousness and relatedness assessments, send follow-up SAEs/AEs queries to relevant sites or reporters. The Safety Specialists create patient adverse event narratives,drafts of aggregate reports, assist in the preparation of files for archiving, and transfer to client.
If you have:
then this is the right place for you.