- Sumitomo Pharma (Sacramento, CA)
- …English. **Education and Experience** + **Medical Degree (MD) with 3-5 years of drug safety experience in a pharmaceutical company** + Experience in oncology ... Mitigation Strategy (REMS) + Contributes to PVRM and cross-functional drug development teams and manages Safety Charters...+ Prepares and presents safety information (ie safety graphs, tables, and reports) to project … more
- BeOne Medicines (Emeryville, CA)
- …Medical Monitoring Plans, CSRs (incl. China ADR Summary) and other relevant project /study documents and answer ad-hoc safety queries from ethics committees. ... sections of global regulatory inquiries and periodic reports including Development Safety Update Reports (DSURs), Periodic Adverse Drug . Experience Report… more
- BeOne Medicines (San Mateo, CA)
- …Medical Monitoring Plans, CSRs (incl. China ADR Summary) and other relevant project /study documents and answer ad-hoc safety queries from ethics committees ... sections of global regulatory inquiries and periodic reports including Development Safety Update Reports (DSURs), Periodic Adverse Drug Experience Report… more
- Nestle (Brisbane, CA)
- …Deep understanding of biotech/pharmaceutical manufacturing systems and processes supporting drug safety , pharmacovigilance , manufacturing, engineering ... new GxP systems to support NHSc product portfolio. + Serve as Project Manager for technology implementations, including coordination and management of external… more
- ThermoFisher Scientific (Carlsbad, CA)
- …presents sponsor meetings, provides medicines and device development consultation to clients and project team members in direct support of sales efforts. + Serves as ... effectively with key internal directorates including Operations, Biometrics, Regulatory, Pharmacovigilance , and Global Product Development to ensure the best… more
- AbbVie (South San Francisco, CA)
- …AbbVie's customers, markets, business operations, and emerging issues. Oversees project -related education of investigators, study site personnel, and AbbVie study ... integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is… more
- AbbVie (Irvine, CA)
- …AbbVie's customers, markets, business operations and emerging issues. Oversee project -related training of investigators, study site personnel, and AbbVie study ... interpretation, and communication of accumulating data pertaining to botulinum toxin safety and efficacy in aesthetic indications. Along with Clinical Operations,… more
- AbbVie (Irvine, CA)
- …AbbVie's customers, markets, business operations, and emerging issues. Oversee project -related training of investigators, study site personnel, and AbbVie study ... interpretation, and communication of accumulating data pertaining to botulinum toxin safety and efficacy in varied indications. Along with Clinical Operations,… more