IDEAYA Biosciences · 4 hours ago
Senior Manager, Drug Safety Operations
South San Francisco, CA
Full-time
Hybrid
Senior Level
$184K/yr - $227K/yr
5+ years expIDEAYA Biosciences is a precision medicine oncology company focused on developing transformative therapies for cancer. The Senior Manager, Drug Safety Operations will oversee Individual Case Safety Report management, ensuring operational excellence and compliance while collaborating with various stakeholders.
BiotechnologyHealth CareOncologyTherapeutics
Responsibilities
Provide end-to-end operational oversight of ICSR intake, processing, follow-up, quality control, and regulatory submissions performed by outsourced PV vendors
Maintain retained oversight of vendor case-processing workflows to ensure accuracy, consistency, and compliance with IDEAYA SOPs and PV system expectations
Coordinate internal medical review activities (e.g., seriousness, expectedness, narratives, reporting decisions) in collaboration with Safety Physicians
Monitor case flow, prioritization, and handoffs to ensure timely submissions and adherence to internal quality standards
Review operational trends and quality indicators to proactively identify risks and drive corrective actions
Provide day-to-day operational oversight of PV CROs, ensuring adherence to SOWs, SLAs, SOPs, and defined workflows
Lead and facilitate routine operational governance meetings with pharmacovigilance vendors, including review of metrics, case quality, issues, and action items
Define, monitor, and present ICSR KPIs related to timeliness, quality, completeness, intake performance, and query aging
Analyze vendor and operational data to identify inefficiencies, quality risks, and continuous improvement opportunities
Lead standardization and optimization of ICSR workflows across programs and vendors
Escalate vendor performance or compliance risks with clear, data-driven recommendations
Oversee configuration of a new study in Safety Data base including reporting rules, workflows, product configuration, and regulatory reporting parameters
Partner with vendors, Safety Scientists, Regulatory Operations, and GxP IT as needed to ensure accurate and timely implementation of study configurations
Support validation documentation, user acceptance testing (UAT), and go-live readiness for new studies from an operational perspective
Provide regular operational and vendor performance updates to the Director of Safety Operations
Support establishment of the Pharmacovigilance System Master File (PSMF) by contributing operational descriptions of ICSR processes, vendor models, interfaces, metrics, and retained oversight activities
Partner with the QPPV and Deputy QPPV to ensure ICSR operations are appropriately designed, implemented, and documented within the PV system
Identify operational gaps or risks during PSMF build and support mitigation planning
Once active, support ongoing PSMF updates by communicating operational changes and ensuring ICSR practices remain aligned with the approved PSMF
Support internal audits and regulatory inspections related to ICSR operations and vendor execution
Serve as the ICSR operational SME during inspections, including walkthroughs of case workflows, metrics, and vendor oversight practices
Support preparation of inspection materials and responses and assist with CAPAs related to ICSR operational findings, in collaboration with Quality and PV System Oversight
Partner closely with Safety Physicians and Safety Scientists to support medical review, case assessment, and signal detection activities if needed
Support safety data needs for DSURs, IBs, and other aggregate safety deliverables as they relate to ICSR data quality and availability
Facilitate effective communication between internal teams and external vendors regarding ICSR workflows
Qualification
Required
Bachelor's degree in life sciences, health sciences, pharmacy, nursing, or a related discipline required
5+ years of pharmacovigilance experience with direct involvement in ICSR processing and/or operational oversight
Experience working with safety databases (e.g., Oracle Argus)
Experience managing or overseeing PV vendors in an outsourced model
Advanced Microsoft Excel skills (e.g., data analysis, pivot tables, KPI dashboards)
Strong presentation and communication skills, including presenting operational metrics and recommendations to management
Experience supporting audits and regulatory inspections for ICSR operations
Strong analytical and metrics-driven operational mindset
Experience in clinical development and/or post-marketing environments
Strong operational leadership and execution focus
Deep ICSR subject matter expertise
Vendor management and performance oversight
Clear communication and escalation judgment
Cross-functional collaboration
Preferred
Advanced degree (Master's, PharmD, RN) preferred but not required
Benefits
Medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents)
401k
ESPP
Wellness programs
Company
IDEAYA Biosciences
IDEAYA Biosciences is an oncology-focused biotechnology company that develops therapeutics for patients with genetically-defined cancers.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$694.1MKey Investors
5AM Ventures
2024-07-09Post Ipo Equity· $263M
2023-10-24Post Ipo Equity· $125M
2022-09-14Post Ipo Equity· $80M
Leadership Team
Yujiro S. Hata
CEO
Paul A. Stone
Chief Financial Officer & General Counsel
Recent News
2025-12-16
Company data provided by crunchbase