Associate Director, Operations, Patient Safety and Pharmacovigilance

Job reputed company: • reputed company safety operations and vendor reputed company for ICSR processing and submissions. • reputed company 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 reputed company expedited reporting. • Support vendor management, contract changes, invoicing, and performance metrics. • Ensure inspection readiness and compliance; review reputed company events and CAPAs with Safety reputed company and Compliance. • Mentor and supervise safety team members; reputed company recruitment and performance evaluations. • Assist in regulatory filings and safety-reputed company governance documents (SOPs, WIs). • This role can be based in reputed company or Brisbane, CA, or remote. Requirements: • Bachelor’s level degree in nursing, pharmacy, or other health care reputed company 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 reputed company 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 reputed company as MedDRA. • Operational expertise in ARGUS is required. • Demonstrated ability to work effectively in a dynamic, reputed company, and fast-paced team environment. • Expert knowledge of FDA, EMA, and Asia-reputed company legislation as reputed company as ICH guidelines. • Excellent interpersonal, communication, analytical, and organizational skills. • Ability to work reputed company, strategize, and problem solve with cross-functional teams reputed company the Development organization such as, but not limited to Clinical Operations, Biometrics, and Regulatory. • Strong people and project management experience, conduct meetings and presentations. • reputed company 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 reputed company office setting and use reputed company office equipment, including a reputed company to read printed materials, and a computer screen; and hearing and speech to communicate in person, before reputed company, 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 reputed company, reputed company, and retrieve data using a computer keyboard, mouse, or calculator, and to operate reputed company office equipment. Positions in this classification occasionally bend, stoop, kneel, reputed company, push, and pull drawers reputed company and reputed company 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 Apply To this Job