Drug Safety Manager, Drug Safety Compliance and Vendor Oversight
About the position We are seeking a Drug Safety Manager, Compliance and Vendor oversight who supports the oversight of IDEAYA’s Drug Safety activities to ensure adherence to internal SOPs, contractual obligations, and applicable global regulatory requirements. This role provides independent compliance and system oversight for Drug Safety activities performed internally and by all pharmacovigilance vendors working on behalf of IDEAYA, ensuring consistent application of procedures and expectations across vendors operating under Safety Data Exchange Agreements (SDEAs). The role does not perform case processing or system administration. Instead, it focuses on monitoring controls, identifying risks, supporting remediation, and maintaining inspection readiness of the pharmacovigilance system. This position is based in our South San Francisco headquarter offices and required to be onsite four days per week per our company policy.
Responsibilities
- Pharmacovigilance System & Compliance Oversight 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.
- SOP Governance & Process Alignment 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.
- Vendor, SDEA & System Oversight 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.
- Deviations, Corrective Actions & Metrics 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.
- Audit & Inspection Support 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.
Requirements
- 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
- All employees are expected to act with integrity and in full compliance with applicable laws, regulations, App