- Sumitomo Pharma (Sacramento, CA)
- …highly motivated, and experienced individual for the position of **Associate Medical Director .** The Associate Medical Director will provide hands-on PVRM ... evaluation reports according to established safety governance policies and keeping senior leadership informed of safety issues. **Job Duties and Responsibilities** +… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** The Associate Director , Good Pharmacovigilance Practice (GVP) Audits, serves as a key ... lead complex audits across the broader R&D, vendor, and pharmacovigilance workstreams. This position requires close collaboration with cross-functional stakeholders,… more
- Ascendis Pharma (Palo Alto, CA)
- …offer a dynamic workplace for employees to grow and develop their skills. The Director , Head, ICSR Management Team reports to the Head, Global PV Operations within ... the direction of the Head, Global PV Operations, the Director , ICSR Management Team is responsible for the oversight...working on a diverse scope of activities to ensure pharmacovigilance regulations/ guidelines are adhered to. + Responsible for… more
- BeOne Medicines (Emeryville, CA)
- The Senior Director , Clinical Development, Solid Tumors will support BeOne Clinical and Medical assets by successful execution of clinical development programs ... colleagues in clinical development, program leadership, biometrics, clinical operations, safety/ pharmacovigilance , regulatory, molecular diagnostics, and translational research. **Essential Functions… more
- AbbVie (Irvine, CA)
- …Medical Director manages other Associate Medical Directors, Medical Directors, Senior Medical Directors. Leading Product Safety Teams (PST) and PST leads (and ... signal detection, validation and assessment). Interpreting regulations related to pharmacovigilance supporting all patient safety activities. Experts on hematology-oncology… more
- AbbVie (Irvine, CA)
- …for key regulatory discussions. *Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality ... standards in conducting research. Qualifications *Bachelors degree in the sciences; advanced degree (eg, MS, PhD, OD, MD, PharmD) preferred. *At least 8 years of product development experience with 5 years of experience in consumer eye care in the… more
- Gilead Sciences, Inc. (Foster City, CA)
- …in cross-functional projects and teams with responsibilities related to pharmacovigilance and quality system activities. + Significant experience leading quality, ... industry, including significant relevant experience working in quality, compliance, pharmacovigilance , or a related field. + Extensive experience leading GCP… more
- Bausch + Lomb (Sacramento, CA)
- …consultants to ensure study objectives are being met and provide the operations director and/or senior management with timely updates on progress and changes ... R&D/Project Management, Clinical/Medical Affairs, Biometrics, Regulatory Affairs, Quality Assurance, Pharmacovigilance /GPSS and Drug/Device Safety, and Clinical Supplies), and external… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- **Job Summary** We are seeking an experienced and dynamic Executive Director of R&D Global Quality to join our team. This pivotal role will be responsible for ... of the Quality Systems and Risks will be reported periodically to Senior Management through the Management Review process to ensure alignment with Company… more
- Taiho Oncology (Pleasanton, CA)
- …assessments for the study conduct and operational risks. Represent the molecule at senior management governance meetings. + Mentoring and training of junior staff in ... cross-functional areas (eg, clinical operations, biostatistics, data management, biomarker, pharmacovigilance , quality, etc.) + Knowledge in authoring key clinical… more