- 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)
- General Description: _The Director , Safety Scientist supports assigned compounds in conjunction with Product Safety Leads (PSLs) and leverages clinical and ... of global regulatory inquiries and periodic reports including Development Safety Update Reports (DSURs), Periodic Adverse Drug ....depending on the program / portfolio being led. The Director , Safety Scientist provides key support as… more
- United Therapeutics (Sacramento, CA)
- …enjoy being part of a collaborative team. The Associate Global PV Case Management Director plays a key role in management and oversight of end-to-end case safety ... 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 ... The Executive Director , Clinical I/O Development will support BeOne Medicine's...2 studies in late development) + Seamless transition of drug candidates from research to early clinical development +… more
- BeOne Medicines (San Mateo, CA)
- …in clinical development, program leadership, biometrics, clinical operations, safety / pharmacovigilance , regulatory, molecular diagnostics, and translational ... The Director , Clinical Development, Solid Tumors will support BeOne...applications), NDAs (and equivalent applications), Annual Reports, and Developmental Safety Update Reports + Clinical sections of Health Authority… more
- BeOne Medicines (San Mateo, CA)
- …in clinical development, program leadership, biometrics, clinical operations, safety / pharmacovigilance , regulatory, molecular diagnostics, and translational ... The Senior Director , Clinical Development, Solid Tumors will support BeOne...applications), NDAs (and equivalent applications), Annual Reports, and Developmental Safety Update Reports + Clinical sections of Health Authority… more
- AbbVie (South San Francisco, CA)
- …LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Medical Director leads the direction, planning, execution, and interpretation of clinical ... 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)
- …to providing the most comprehensive science-based product offerings available. The Director II, Clinical Development will oversee the direction, planning, execution, ... interpretation, and communication of accumulating data pertaining to botulinum toxin safety and efficacy in aesthetic indications. Along with Clinical Operations,… more
- AbbVie (Irvine, CA)
- …interpretation, and communication of accumulating data pertaining to botulinum toxin safety and efficacy in varied indications. Along with Clinical Operations, ... related to botulinum toxin and aesthetic clinical studies and global drug development, exemplifying compliance with those requirements. Provide clinical development… 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