- Nestle (Brisbane, CA)
- …Deep understanding of biotech/pharmaceutical manufacturing systems and processes supporting drug safety , pharmacovigilance , manufacturing, engineering ... automation, regulatory compliance, quality management and compliance, medical information, or clinical trials applications. + IT working knowledge in a biotech research lab environment, familiar with lab systems implementation and system requirements, clinical… 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 ... Evaluation and Mitigation Strategy (REMS) + Contributes to PVRM and cross-functional drug development teams and manages Safety Charters + Handles Health… more
- BeOne Medicines (Emeryville, CA)
- … sections of global regulatory inquiries and periodic reports including Development Safety Update Reports (DSURs), Periodic Adverse Drug . Experience Report ... General Description: _The Director, Safety Scientist supports assigned compounds in conjunction with Product Safety Leads (PSLs) and leverages clinical and… more
- Ascendis Pharma (Palo Alto, CA)
- …B. Pharm, PharmD, RN etc.) + Candidates with advanced scientific degrees and extensive drug safety experience is highly desired. + Minimum of 10 years recent ... 5 years of people management experience (preferred). + Working knowledge of validated Drug Safety Databases (Argus preferred) + Experience with MedDRA coding and… more
- BeOne Medicines (San Mateo, CA)
- … sections of global regulatory inquiries and periodic reports including Development Safety Update Reports (DSURs), Periodic Adverse Drug Experience Report ... **_General Description:_** The Senior Manager, Safety Scientist supports assigned compounds in conjunction with...integrated Benefit/Risk assessments Promote and Advance the Field of Pharmacovigilance . Any other tasks assigned by manager to… more
- United Therapeutics (Sacramento, CA)
- …plays a key role in management and oversight of end-to-end case safety management activities spanning across our global commercial product portfolio. This position ... to ensure compliance with global regulations and guidelines with regards to safety data collection, management and reporting for postmarketing ICSRs for efficiency,… more
- BeOne Medicines (San Mateo, CA)
- …in clinical development, program leadership, biometrics, clinical operations, safety / pharmacovigilance , regulatory, molecular diagnostics, and translational ... and up to 2 studies in late development) + Seamless transition of drug candidates from research to early clinical development + Effective integration of in-licensed… 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
- 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 (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