IDEAYA Biosciences · 8 hours ago
Drug Safety Manager, Drug Safety Compliance and Vendor Oversight
South San Francisco, CA
Full-time
Onsite
Mid, Senior Level
$145K/yr - $180K/yr
4+ years expIDEAYA Biosciences is a precision medicine oncology company focused on developing transformative therapies for cancer. The Drug Safety Manager will oversee compliance of Drug Safety activities and ensure adherence to regulatory requirements while supporting the oversight of pharmacovigilance vendors.
BiotechnologyHealth CareOncologyTherapeutics
Responsibilities
Oversee compliance of Drug Safety activities adhere to IDEAYA SOPs, work instructions, and applicable regulatory requirements
Monitor consistency of Drug Safety execution across internal teams and vendors
Identify compliance risks, trends, or gaps and escalate findings with clear documentation and recommendations
Support governance and lifecycle management of Drug Safety SOPs work instructions and related procedures
Ensure procedure remains current, clearly written, and inspection ready aligned with regulatory expectations, and inspection ready
Support SOP training, retraining, and effectiveness checks for internal staff and applicable vendor personnel
Assess alignment between documented procedures and operational practice
Provide consistent compliance oversight across all pharmacovigilance vendors performing activities for IDEAYA
Support oversight of SDEAs to ensure roles, responsibilities, data exchange requirements, and escalation pathways are defined and followed
Monitor vendor compliance with timelines, data quality standards, and documentation requirements using metrics and oversight reviews
In collaboration with IDEAYA GxP IT, support oversight of vendor-used systems supporting Drug Safety activities, including user access controls, access reviews, business continuity and disaster recovery preparedness, and data protection
Review vendor documentation and evidence supporting system and compliance readiness
Document, escalate, and track remediation of vendor- or system-related gaps or risks. Collaborate with Senior Manager, Drug Safety Operations to ensure operational execution aligns with compliance expectations
Oversee identification and documentation of internal Drug Safety deviations and non-compliance events
Provide oversight of vendor Quality Events (QEs) documented in accordance with vendor SOPs, ensuring appropriate notification, classification, investigation, and CAPA development meet IDEAYA, GVP, and contractual expectations
Lead review and governance of root cause analyses and CAPAs for vendor QEs, assessing adequacy, timeliness, and effectiveness
Trend and analyze deviations, vendor QEs, and CAPAs to identify recurring or systemic compliance risks and drive risk-based escalation and mitigation
Define, implement, and oversee Drug Safety compliance metrics and KPIs, ensuring consistent monitoring
Support preparation for regulatory inspections and internal audits related to Drug Safety and pharmacovigilance compliance
Serve as a compliance subject matter expert during inspections, providing support for documentation requests, and evidence generation
Support development, review, and tracking of inspection responses, commitments, and post-inspection remediation activities
Qualification
Required
Bachelor's degree in life sciences, pharmacy, nursing, public health, or related discipline with 4+ years of experience in pharmacovigilance, Drug Safety, or a related regulated environment
Working knowledge of Drug Safety regulatory requirements
Experience supporting SOPs, compliance activities, or quality processes
Exposure to vendor-supported or outsourced service models
Strong documentation, analytical, and organizational skills
Ability to identify risks and escalate issues appropriately
Experience supporting audits or inspections
Familiarity with Safety Data Exchange Agreements (SDEAs)
Experience working with quality or compliance systems
Experience collaborating with IT or system owners on compliance topics
Compliance-focused mindset
Attention to detail and documentation discipline
Risk awareness and sound judgment
Cross-functional collaboration
Ability to influence without direct authority
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