- Gilead Sciences, Inc. (Santa Monica, CA)
- …to support pipeline planning as well as US safety and pharmacovigilance activities, (3) development of strategically aligned scientific publications using real-world ... of IND submissions, clinical trial applications, filing procedures, or pharmacovigilance /safety inquiries. + Develop, execute and deploy integrated evidence… more
- Deloitte (San Francisco, CA)
- …include: + Project Leadership: Lead the delivery of and pharmacovigilance projects, including business process transformation, technology enablement, and regulatory ... Engineering, or related field + 4+ years of experience in life sciences, pharmacovigilance , or consulting + 4+ years of experience implementing and working with… 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. + Completion of… more
- Ascendis Pharma (Palo Alto, CA)
- …+ Raise or increase awareness, knowledge and understanding of pharmacovigilance requirements by conducting education/training sessions with functional partners / ... experience is highly desired. + Minimum of 4 years recent experience in Pharmacovigilance + Working knowledge of validated Drug Safety Databases (Argus preferred) +… more
- System One (Alameda, CA)
- …QA is accountable for Good Clinical Practices (GCP) and Good Pharmacovigilance Practices (GVP) systems and activities, drives compliance and continuous improvement, ... ensures that Quality is integrated throughout GCP/GVP processes, supports and conducts audits as requested using a risk-based approach, implements Quality Risk Management (QRM), tracks and trends key metrics, and ensures clinical data integrity. Education: +… more
- Genentech (South San Francisco, CA)
- …(eg, confidentiality, intellectual property, data privacy, interactions with customers, pharmacovigilance ) and proactively manage risk in external collaborations and ... evidence generation, ensuring alignment with Roche standards, legal frameworks, and evolving global regulatory expectations. External Partnerships & Community Impact + Lead strategic partnerships and serve as a senior medical spokesperson to advance population… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …+ 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 Services Research or Public Health,… more
- Cytel (Sacramento, CA)
- …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 guidance to… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …**Stakeholder Engagement** : Collaborate with Clinical Operations, Regulatory Affairs, Pharmacovigilance , and other functions to ensure alignment on quality ... expectations and audit outcomes. + **Continuous Improvement** : Identify trends and systemic issues from audit findings and contribute to the development of global quality improvement initiatives. + **Training & Guidance** : Provide GCP compliance training and… more
- AbbVie (Irvine, CA)
- …Management (QRM), covering multiple domains such as Clinical Operations, Pharmacovigilance , pre-Clinical, or Manufacturing. + Deep knowledge of global regulatory ... frameworks, inspection readiness, compliance standards, and QRM methodologies, including maintenance of risk logs/registers. + Demonstrated capability to standardize and scale quality and risk management processes globally to enhance operational efficiency and… more