- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …guidelines + Expertise in therapeutic products and areas; medical coding; safety -data administration + Pharmacovigilance Specialist should possess autonomy and ... and regions. **_Job Summary:_** Provides operational support for global pharmacovigilance activities of Grifols marketed products. Ensures pharmacovigilance … more
- BeOne Medicines (San Mateo, CA)
- …field or biological science and 4+ years of experience as a Safety ( Pharmacovigilance ) Scientist.ORMD (or internationally recognized equivalent) plus accredited ... **General Description:** _The Associate Director, Safety Scientist supports assigned compounds in conjunction with Product Safety Leads (PSLs) and leverages… more
- Ascendis Pharma (Palo Alto, CA)
- …issues are identified. . Assists Head of GPS Medical Science for patient safety and pharmacovigilance activities for ensuring corporate compliance with all ... Pharmacovigilance Department direction, standards, and processes for supporting safety monitoring activities. . Collaborates closely with the Medical Assessment… more
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …like you. Role Mission: Provide operational support for global pharmacovigilance activities related to Grifols' investigational and marketed products. Ensure ... high-quality pharmacovigilance deliverables that comply with global regulatory reporting timelines. Manage project implementation and execution of safety … 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
- 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
- Sumitomo Pharma (Sacramento, CA)
- …for SMPA investigational and commercial products. The incumbent will provide medical safety support for safety signal management throughout product lifecycle ... strategies and authoring of signal evaluation reports according to established safety governance policies and keeping senior leadership informed of safety… more
- Ascendis Pharma (Palo Alto, CA)
- …Safety Database. + Reviews and provides input to Business Partner or Pharmacovigilance Agreements and Safety Data Exchange Agreements (SDEA) to ensure ... the Head, Global PV Operations within the Global Patient Safety (GPS) organization. Under the direction of the Head,...working on a diverse scope of activities to ensure pharmacovigilance regulations/ guidelines are adhered to. + Responsible for… more