Specialist, Pharmacovigilance Operations

The Role:

Reporting to the Director, PV Operations – Case Processing, this role will be responsible for effective execution of the activities of triage, processing, and, quality control of individual case safety reports (ICSR) from Moderna clinical trials to ensure timely and accurate assessment of adverse event reports. This role will focus on accurate case entry and writing a detailed narrative to describe adverse events reported in clinical trials. The team in Warsaw, Poland will play a critical role in processing all of our pivotal clinical trial cases.

Here’s What You’ll Do:

• Review, rank, verify, process and document case-related information: event terms; validity, seriousness, special scenarios; timelines; accuracy and consistency. Process cases based on these assessments
• Use source documents received to write a comprehensive narrative describing the adverse event appropriately
• Process safety d...