- 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)
- …Today, we're advancing programs in Endocrinology Rare Disease and Oncology. The Sr. Director , Regulatory Affairs will serve as the therapeutic area head for assigned ... and clinical trials as well as Life Cycle Management Strategies. The Sr. Director will work closely with the executive team to formulate strategies, enhance… more
- Pfizer (South San Francisco, CA)
- **Job Summary** The Senior Medical Director provides clinical development leadership and expertise for late-stage thoracic oncology clinical trials directly, ... They work closely with other functions such as regulatory affairs, pharmacovigilance , biostatistics, and medical affairs to ensure that the clinical development… 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
- Ascendis Pharma (Palo Alto, CA)
- …the assigned Vendor Management activities in Ascendis. Key Responsibilities Pharmacovigilance related responsibilities over GVP, Patient Support Programs (PSPs) and ... + Raise or increase awareness, knowledge and understanding of pharmacovigilance requirements by conducting education/training sessions with functional partners /… 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
- BeOne Medicines (Emeryville, CA)
- …Operations Strategy & Innovation and will interact at all levels, including BeOne's Senior Management. This role will manage the submission teams for North America, ... areas such as CMC, Reg Strategy, Clinical/Non-Clinical, Quality/Manufacturing, GTS, Pharmacovigilance and Regulatory Compliance. This position will also play a… more
- Ascendis Pharma (Palo Alto, CA)
- …Management Leads working on a diverse scope of activities to ensure pharmacovigilance regulations/ guidelines are adhered to. + Responsible for managerial oversight ... regards to budget, headcount, people and organizational development. + Participates with senior management to establish strategic plans and objectives. + Acts as an… more