Job Summary
A biopharmaceutical company has a current position open for a Remote Senior Safety Operations and Compliance Director.
Individual must be able to fulfill the following responsibilities:
- Be responsible for safety inspection readiness activities
- Serve as the Safety subject matter expert for internal audits and global inspections
- Review the safety sections of clinical documents
Skills and Requirements Include:
- Minimum of 10 years' experience in Pharmacovigilance
- Thorough knowledge and experience in safety reporting in both the clinical trial and post-market settings
- Track record of strong personal performance
- Demonstrates the ability to handle increasing responsibilities
- Extensive experience participating in inspections/audits and leading efforts around related CAPAs
- Strong knowledge and experience with available drug safety database systems, document management systems, and QC tools
