Job Description Summary

Primarily responsible for all activities related to the Global Pharmacovigilance (GPV) Central Safety Unit (CSU) processing of Individual Case Safety Report (ICSR) information from all sources—including post-marketing, clinical trials, and published literature. Additionally, as a more advanced case processor, responsible for activities that support training, compliance, regulation changes, and the shaping of process improvements.

Essential Responsibilities

• Receive, triage and process adverse events and medical device reports from all sources—including post-marketing, clinical trials, and published literature.
• Perform initial assessment of seriousness, expectedness, causality, and reportability in accordance with GPV processes and global regulatory requirements and guidelines.
• Perform data entry and quality review of adverse event reports into the global safety database, including accurate coding of MedDRA ter...