- Gilead Sciences, Inc. (Santa Monica, CA)
- …clinical trials, including assessment of eligibility criteria, toxicity management, and drug safety surveillance. + Ensures adherence to regulatory requirements ... initiation visits with clinical trial investigators + Implement and deploy drug development strategic plans, develop contingency plans, provide technical and… more
- Robert Half Office Team (Signal Hill, CA)
- …with calendar management, scheduling, and coordinating multiple activities. * Knowledge of drug safety protocols and case management. * Experience with training ... * Provide administrative support to the Environmental Health & Safety department, including managing purchase orders, invoices, reports, meeting agendas,… more
- Parexel (Sacramento, CA)
- …study design/execution, preferred + Clinical practice experience + Good knowledge of the drug development process including drug safety , preferred + ... therapeutic expertise and some experience across indications, clients and drug development. They initiate and maintain medical and consultative relationships… more
- Parexel (Sacramento, CA)
- …level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to ... and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good… more
- Genentech (South San Francisco, CA)
- …guidance. + You perform oversight activities to ensure timely and accurate drug safety monitoring, including Adverse Event (AE) triage, evaluation, prompt ... All responsibilities are performed under the direction of the US Patient Safety PV Clinical Management. Contributes in-depth knowledge of Individual Case Safety… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Biostatisticians, Clinical Research Associates, Clinical Data Managers and other Clinical, Global Drug Safety , Regulatory and Project Management staff to meet ... responsible for the business, operational, and compliance aspects of Virology drug discovery, development, and marketed products at Gilead. He/she will support… more
- Sumitomo Pharma (Sacramento, CA)
- …authoring clinical sections for INDs, NDAs, and other related documents. + Partner with Drug Safety & Pharmacovigilance to assess the safety profile of ... monitoring overall study integrity, and review, interpretation, and communication of safety and efficacy data. + Present at scientific, medical, and regulatory… more
- 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 ... regulatory reporting timelines. Manage project implementation and execution of safety systems, including ongoing business support and continuous improvement… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Biostatisticians, Clinical Research Associates, Clinical Data Managers and other Clinical, Global Drug Safety , Regulatory and Project Management staff to meet ... responsible for the business, operational, and compliance aspects of Oncology drug discovery, development, and marketed products at Gilead. He/she will support… more
- Gilead Sciences, Inc. (Foster City, CA)
- …but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance. + Manages the clinical development component(s) in ... Experience** + MD or equivalent with 2+ years' clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia or… more