Associate Director, Operations, Patient Safety and Pharmacovigilance

Job Description: • Lead safety operations and vendor oversight for ICSR processing and submissions. • Oversee global safety database (Argus) configuration, updates, workflows, and reporting. • Coordinate serious adverse events (SAEs) processing with safety vendor across trials and programs. • Manage ICSR case management, data exchange with partners, and timely expedited reporting. • Support vendor management, contract changes, invoicing, and performance metrics. • Ensure inspection readiness and compliance; review quality events and CAPAs with Safety Quality and Compliance. • Mentor and supervise safety team members; oversee recruitment and performance evaluations. • Assist in regulatory filings and safety-related governance documents (SOPs, WIs). • This role can be based in Hayward or Brisbane, CA, or remote. Requirements: • Bachelor’s level degree in nursing, pharmacy, or other health care related fields • 6+ years in Safety and Pharmacovigilance in the pharmaceutical industry setting; 4+ years managing contracted safety vendors • Oncology experience is preferred • Demonstrated ability to create, evaluate and maintain effective business processes and implement procedures, systems, and tools to maximize resources within the Safety department. • Thorough knowledge and experience in safety reporting in both the clinical trial and post-market settings. • Strong knowledge and experience with available drug safety database systems, document management systems, QC tools, as well as MedDRA. • Operational expertise in ARGUS is required. • Demonstrated ability to work effectively in a dynamic, complex, and fast-paced team environment. • Expert knowledge of FDA, EMA, and Asia-PAC legislation as well as ICH guidelines. • Excellent interpersonal, communication, analytical, and organizational skills. • Ability to work well, strategize, and problem solve with cross-functional teams within the Development organization such as, but not limited to Clinical Operations, Biometrics, and Regulatory. • Strong people and project management experience, conduct meetings and presentations. • Track record of strong personal performance combined with demonstrated ability to collaborate and build high performing teams. • Physical Requirements Office Setting Must possess mobility to work in a standard office setting and use standard office equipment, including a computer; vision to read printed materials, and a computer screen; and hearing and speech to communicate in person, before groups, and over the telephone. This is primarily a sedentary office classification although standing in work areas and walking between work areas may be required. Finger dexterity is needed to access, enter, and retrieve data using a computer keyboard, mouse, or calculator, and to operate standard office equipment. Positions in this classification occasionally bend, stoop, kneel, reach, push, and pull drawers open and closed to retrieve and file information. Employees must possess the ability to lift, carry, push, and pull materials and objects weighing up to 25 pounds. Benefits: • Stock programs • Performance-based bonus • Comprehensive benefits package • Information about total rewards program Apply tot his job