- Sumitomo Pharma (St. Paul, MN)
- …safety guidance and input to key documents, including Investigator Brochures (IBs), informed consent forms (ICFs), protocols, study reports, regulatory reports, ... medical history) and support preparation of investigator brochures, protocols, informed consent documents, final study reports, and other relevant safety… more
- Sumitomo Pharma (St. Paul, MN)
- … safety subject matter expert (SME) on behalf of PVRM for: Study Protocols, Informed Consent Forms (ICF), Safety Management Plans (SMP), Clinical Study Reports ... signal evaluation reports according to established safety governance policies and keeping senior leadership informed of safety issues. **Job Duties and… more