- BeOne Medicines (Emeryville, CA)
- …medical field or biological science and 8+ years of experience as a Safety ( Pharmacovigilance ) Scientist. + MD (or internationally recognized equivalent) plus ... **General Description:** The Director, Safety Scientist supports assigned compounds in conjunction with Product Safety Leads (PSLs) and leverages clinical and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …+ MD or equivalent with 4+ years of experience in drug safety / pharmacovigilance , with a focus on clinical trials and cross-functional collaboration ... **Preferred Qualifications:** + 5+ years of experience in drug safety / pharmacovigilance , with a focus on clinical trials and cross-functional collaboration. +… more
- Parexel (Sacramento, CA)
- …this pivotal role, you'll perform comprehensive medical reviews, provide expert safety monitoring, and deliver pharmacovigilance guidance across assigned ... all Key Performance Indicators (KPIs) for the process + Function as pharmacovigilance representative/ safety scientist + Attend/support Bid defense meetings +… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …(2) epidemiological expertise to support pipeline planning as well as US safety and pharmacovigilance activities, (3) development of strategically aligned ... context of IND submissions, clinical trial applications, filing procedures, or pharmacovigilance / safety inquiries. + Develop, execute and deploy integrated… more
- Parexel (Sacramento, CA)
- …**medical monitoring** and clinical trial design/execution + Knowledge of drug safety and pharmacovigilance processes **Essential Skills** + **Exceptional ... **Medical Monitor** for gastroenterology studies, ensuring scientific integrity and patient safety + Provide expert medical oversight throughout the clinical trial… 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 (Emeryville, CA)
- …in clinical development, program management, 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)
- …clinical sections for INDs, NDAs, and other related documents. + Partner with Drug Safety & Pharmacovigilance to assess the safety profile of compounds. ... monitoring overall study integrity, and review, interpretation, and communication of safety and efficacy data. + Present at scientific, medical, and regulatory… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …site selection and performance. + Support other areas of the organization including Safety & Pharmacovigilance for investigation of safety -related issues, ... Sales Training medical education on an ongoing basis including new hire and POAs, and the Field Medical Center of Excellence for mentoring and sharing of best practices. **Qualifications** + Advanced degree in Pharmacy, Medicine, Biological Sciences, Health… more
- Cytel (Sacramento, CA)
- …skill set, the role may also include strategic consulting on clinical, safety / pharmacovigilance , regulatory, and market access pathways to accelerate patient ... access to new health technologies. **Client Leadership & Strategic Advisory** + Serve as an externally recognized thought leader in clinical development, regulatory strategy, market access strategy, and quantitative clinical methods. + Provide strategic… more