**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.

**Job Description**

**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 accur...