Manager/Sr. Manager Safety Operations
Locations: Brisbane, California | Hayward, California | Remote, United States
Manager/Sr. Manager Safety Operations
We are searching for a creative, resourceful, integrative thinker for an important role that will
contribute to safety operations and vendor oversight activities. The Manager/Sr. Manager, Safety Operations will be responsible for supporting with operational management and oversight of case processing activities performed externally by a dedicated vendor. The candidate will contribute to activities such as overall safety operations strategy across the portfolio including case management, database strategy, vendor oversight, compliance, inspection readiness and training to support the company’s success in continued growth and expansion. This position requires a candidate with strong cross-functional skills and communication, a desire to help the team meet fast-paced growth into global territories and be self-motivated.
• Assist with effective vendor management strategies for safety operations related activities and ensure inspection ready documentation of oversight.
• Conduct routine retrospective quality control of SAEs processed by the external vendor to guarantee quality and oversight.
• Ensure the global safety database (Argus) supports the department needs, including specific workflows and reporting/querying functionalities. Provide oversight of system and MedDRA updates in collaboration with the safety vendor.
• Support oversight of safety data exchange with partners in accordance with Safety Data Exchange Agreements.
• Ensure timely submission of expedited safety reports and other external submissions through effective vendor management and performance metrics review. Escalate as appropriate any issues or trends to the Associate Director, Safety Operations and/or Associate Director, Safety Quality and Compliance.
• Provide Safety Operational support to clinical trial study teams as needed, including attending Study Team Meetings, providing comments for consideration in the Safety Management Plans, and training the Clinical Research Associates on SAE reporting processes.
• Collaborate closely with Safety Quality and Compliance to ensure inspection readiness.
• Support the organization with global filing activities for product approval as needed.
• Assist the Safety Operations subject matter expert in preparation for internal audits and global regulatory inspections.
• Minimum of Bachelor’s level degree in nursing, pharmacy, or other health care related field.
• Minimum 4– 6 years in Safety and Pharmacovigilance in the pharmaceutical industry setting.
• 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, and QC tools, as well as MedDRA.
• Operational expertise in ARGUS is preferred.
• 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.
• Strong people and project management experience.
• Track record of strong personal performance combined with demonstrated ability to build and lead high performing teams.
Arcus Biosciences is an equal opportunity employer.
3928 Point Eden Way I Hayward, CA 94545 – Arcus Biosciences is an equal opportunity employer