- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …aggregate reports preparation, signal management and ad hoc requests. + Support drug safety systems through business administration tasks, including database ... deliverables that comply with global regulatory reporting timelines. Manage project implementation and execution of safety systems, including ongoing… more
- 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
- Gilead Sciences, Inc. (Foster City, CA)
- …and help create possible, together. **Job Description** The Associate Director, Good Pharmacovigilance Practice (GVP) Audits, serves as a key role within Gilead's ... lead complex audits across the broader R&D, vendor, and pharmacovigilance workstreams. This position requires close collaboration with cross-functional stakeholders,… 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
- 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
- Sumitomo Pharma (Sacramento, CA)
- …collaboration with external partners **Key Core Competencies** + Strong understanding of pharmacovigilance regulations and drug safety reporting requirements ... Management Team meetings. + Represent PV Operations on cross-functional program and project teams; support PV Medical Safety activities on cross-functional… more
- AbbVie (South San Francisco, CA)
- … safety . + Potentially represent SSG/DSS on external initiatives to advance the drug safety analytics discipline (eg, ASA, PhUSE, DIA, etc.), depending on ... part of collaborative, cross functional teams including members from Pharmacovigilance and Patient Safety (eg, product ...individual interests. + Responsible for project and resource management within SSG for therapeutic area(s)… more
- Bausch + Lomb (Sacramento, CA)
- … Management, Clinical/Medical Affairs, Biometrics, Regulatory Affairs, Quality Assurance, Pharmacovigilance /GPSS and Drug /Device Safety , and Clinical ... the successful completion of these studies. May serve as the primary project team representative for Clinical Operations. **Major areas of Responsibility** **:**… more
- BeOne Medicines (San Mateo, CA)
- …in clinical development, program leadership, biometrics, clinical operations, safety / pharmacovigilance , regulatory, molecular diagnostics, and translational ... applications), NDAs (and equivalent applications), Annual Reports, and Developmental Safety Update Reports; + Clinical sections of Health Authority Briefing… more
- BeOne Medicines (Emeryville, CA)
- …in clinical development, program leadership, biometrics, clinical operations, safety / pharmacovigilance , regulatory, molecular diagnostics, and translational ... applications), NDAs (and equivalent applications), Annual Reports, and Developmental Safety Update Reports + Clinical sections of Health Authority Briefing… more