Description

We are searching for a creative, resourceful, integrative thinker for an important role that will be responsible for safety operations and vendor oversight activities. The Associate Director, Operations Patient Safety and Pharmacovigilance will be responsible to perform operational activities, provide support management and oversight of ICSRs case processing and submissions activities performed externally by a dedicated vendor. The role will be responsible for activities such as overall safety operations, participate in 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 someone with strong cross-functional skills, communication, collaboration, a desire to improve efficiency, help the team meet fast-paced growth, meet departmental and organizational goals and be self-motivated.

Responsibilities

• Support effective vendor management operational activities and participate in strategies for safety operations to ensure compliance and inspection readiness.
• Provide support and input to set up vendor relationships (e.g., business requirements, vendor selection, contract details, vendor oversight/safety management plans).
• Work closely with the head of safety operations and internal stakeholders to provide support on vendor contract related change order, invoicing, usage report, establish unit projections and estimate forecasted units for various projects.
• Work closely with safety operations and safety vendor to 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 in leadership, management and oversight in collaboration with safety vendor on processing of serious adverse events (SAEs) originating from various sources, including but not limited to sponsor clinical trials, business partner clinical trials, Investigator Sponsored Trials, Expanded Access Programs.
• Manage and oversee ICSR case management workflow activities in collaboration with the safety vendor to ensure case quality, safety data exchange with partners and timely submission of expedited safety reports.
• Lead with the safety operations SMEs to manage site query activities for SAEs.
• Collaborate closely with Safety Quality and Compliance to support effective vendor management and performance metrics review.
• Partner with Safety Quality and Compliance, cross functional SMEs, Clinical Quality and safety vendor as to review quality events, identify CAPAs required to address late safety reporting and process deviations.
• Provide Safety Operational support to clinical trial study teams as needed.
• Support and act as the SME for Safety business owner for Rave Safety Gateway activities inclusive of new study start up, and in-stream configuration changes.
• Partner with safety operations team to provide support and when necessary, perform hands on activities related to oversight of safety mailbox, retrospective QC of ICSRs, perform SAE reconciliation, safety data cleaning activities with cross function SMEs.
• Partner with Safety Quality and Compliance, and Clinical Quality in the generation, review, and approval of governing documents, such as SOPs, WIs, Templates, as necessary, and ensure operational implementation.
• Provide support in process gap assessment and process improvement.
• Collaborate closely with Safety Quality and Compliance to ensure inspection readiness.
• Support the organization with global filing activities for product approval.
• When required, serve as a subject matter expert for internal audits and global regulatory inspections.
• Support recruitment, hiring, mentoring, and managing direct report(s), with responsibility for employee performance evaluations.

Qualifications

• 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.

This role can be based at our Hayward or Brisbane, CA location or can be remote based. The anticipated salary range for fully qualified candidates applying for this position is $185,000 - $200,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position. The actual salary may vary based on various factors including, without limitation, individual education, experience, tenure, skills and abilities, internal equity and alignment with market data. In addition to a competitive market-based salary, Arcus offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package. Additional information about our total rewards program can be found here: https://arcusbio.com/careers.

Arcus Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Arcus is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets

LI-EW1