Position Summary:
The Safety Specialist II is an integral part of the safety team at Precision and performs all aspects of the collection, processing, and reporting of individual cases safety reports (ICSR) for clinical trials and/or post-marketing safety programs.
Essential functions of the job include but are not limited to:
- Process ICSRs according to Standard Operating Procedures (SOPs) and project/program- specific safety plans
- Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability
- Enters data into Argus Safety Database
- Code events, medical history, concomitant medications and tests.
- Draft case narratives
- Assesses information to be queried and follows up until information is obtained and queries are satisfactorily resolved
- Participates in the generation of timely, co... Click Apply to read the full job description.