I am partnered with a global biopharmaceutical company is currently looking for a fully remote Case Management Specialist! They have an impressive pipeline of clinical and pre-clinical studies in neuroscience and oncology.
Your responsibilities would include:
- Set-up and maintenance of adverse event workflow, and be responsible for the development of department policies and operating procedures
- Intake, reconciliation and submission of ICSRs
- Creating and maintaining AE intake and ICSR Submissions processes and standards, which includes AE follow-up
Experience required: 2+ years of PV Experience, prior ICSR submission experience and
knowledge and understanding of FDA and International regulations pertaining to adverse events and ICSR requirements