Associate Director, Operations Patient Safety and Pharmacovigilance

Role Summary

The Associate Director, Operations Patient Safety and Pharmacovigilance leads safety operations and vendor oversight activities, overseeing ICSRs case processing and submissions performed by a dedicated vendor. Responsibilities include overall safety operations, strategy across the portfolio (case management, database strategy, vendor oversight, compliance, inspection readiness, and training) to support growth and expansion. Requires strong cross-functional collaboration, communication, and a drive to improve efficiency in a fast-paced environment.

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 with the head of safety operations and internal stakeholders to support vendor contract related change orders, invoicing, usage reports, and forecasted units for projects.
• Collaborate with safety operations and the safety vendor to ensure the global safety database (Argus) supports department needs, including workflows and reporting functionalities.
• Provide oversight of system and MedDRA updates in collaboration with the safety vendor.
• Support leadership and oversight in processing of serious adverse events (SAEs) from various sources (sponsor trials, partner trials, Investigator Sponsored Trials, Expanded Access Programs).
• Manage and oversee ICSR case management workflow activities with the safety vendor to ensure case quality, data exchange with partners, and timely submission of expedited safety reports.
• Lead with safety operations SMEs to manage site query activities for SAEs.
• Collaborate with Safety Quality and Compliance to support vendor management and performance metrics review.
• Partner with Safety Quality and Compliance, cross-functional SMEs, Clinical Quality, and safety vendor to review quality events and identify CAPAs for late reporting and deviations.
• Provide Safety Operational support to clinical trial study teams as needed.
• Act as SME for Safety business owner for Rave Safety Gateway activities including new study start up and configuration changes.
• Partner with safety operations to oversee safety mailbox, retrospective QC of ICSRs, SAE reconciliation, and safety data cleaning with cross-functional SMEs.
• Collaborate with Safety Quality and Compliance and Clinical Quality to generate, review, and approve governing documents (SOPs, WIs, Templates) and ensure implementation.
• Provide process gap assessments and process improvement support.
• Collaborate to ensure inspection readiness.
• Support global filing activities for product approval.
• Serve as SME for internal audits and global regulatory inspections when required.
• Support recruitment, mentoring, and management of direct reports, with responsibility for performance evaluations.

Qualifications

• Bachelor‚Äôs degree in nursing, pharmacy, or other healthcare-related field.
• 6+ years in Safety and Pharmacovigilance in the pharmaceutical industry; 4+ years managing contracted safety vendors.
• Oncology experience preferred.
• Ability to create, evaluate, and maintain effective business processes and implement procedures, systems, and tools to maximize resources within Safety.
• Thorough knowledge of safety reporting in clinical trial and post-market settings.
• Strong knowledge of drug safety database systems, document management systems, QC tools, and MedDRA; operational expertise in ARGUS required.
• Ability to work effectively in a dynamic, fast-paced team environment.
• Expert knowledge of FDA, EMA, and Asia-PAC regulations and ICH guidelines.
• Excellent interpersonal, communication, analytical, and organizational skills.
• Ability to work with cross-functional teams (Clinical Operations, Biometrics, Regulatory) to strategize and problem-solve.
• Strong people and project management experience; able to conduct meetings and presentations.
• Proven track record of building high-performing teams.

Skills

• Safety operations leadership
• Vendor management and oversight
• ICSR and SAE processing
• ARGUS and MedDRA proficiency
• Regulatory knowledge (FDA, EMA, ICH)
• Cross-functional collaboration
• Process improvement
• Documentation and SOP development

Education

• Bachelor‚Äôs degree in nursing, pharmacy, or related healthcare field

Additional Requirements

• Physical requirements: standard office setting; ability to lift up to 25 pounds may be required.
• Location: Hayward or Brisbane, CA, or remote-based.