Snr Drug Safety Specialist
Newark Metro Area, NJ
Experience in writing high quality case narratives particularly for clinical trials.
Experience assessing serious case reports; SAEs
The Drug Safety Specialist is responsible for:
Ensuring that individual Adverse Event Case Reports are evaluated, investigated and accurately documented
- AE CASE MANAGEMENT
- Support the triage of cases conducted by Senior Specialist as needed
- Execute QC on key fields of serious cases
- Update key fields in ARISg based on QC, as needed
- Execute case assessment (review events, determine labeledness, identify co-manifestations, review coding, determine causality)
- Produce Create clear concise clinical case narratives
***ARISg or ARGUS experience highly desired.
***MUST be able to produce a high volume of high quality cases within a busy Drug Safety work environment. Healthcare professionals are preferred.