Drug Safety Manager, Drug Safety Compliance and Vendor Oversight
IDEAYA Biosciences
13 hours ago
On-site
South San Francisco, CA
Operations
Position Summary
We are seeking a Drug Safety Manager, Compliance and Vendor oversight who supports oversight of IDEAYA’s Drug Safety activities to ensure adherence to internal SOPs, contractual obligations, and applicable global regulatory requirements. The role provides independent compliance and system oversight for Drug Safety activities performed internally and by pharmacovigilance vendors under Safety Data Exchange Agreements (SDEAs). It does not perform case processing or system administration; it focuses on monitoring controls, identifying risks, supporting remediation, and maintaining inspection readiness.
Responsibilities
- Oversee compliance of Drug Safety activities with IDEAYA SOPs, work instructions, and applicable regulatory requirements.
- Monitor consistency of Drug Safety execution across internal teams and vendors; identify gaps and escalate with documentation and recommendations.
- Support governance and lifecycle management of Drug Safety SOPs/work instructions; ensure procedures remain current and inspection ready.
- Support SOP training/retraining and effectiveness checks for internal staff and applicable vendor personnel; assess alignment between procedures and operational practice.
- Provide consistent compliance oversight across pharmacovigilance vendors; support oversight of SDEAs (roles, responsibilities, data exchange requirements, escalation pathways).
- Monitor vendor compliance with timelines, data quality, and documentation requirements using metrics and oversight reviews.
- Collaborate with GxP IT to oversee vendor-used systems (access controls/reviews, business continuity & disaster recovery, data protection); review vendor documentation/evidence.
- Document, escalate, and track remediation of vendor/system gaps or risks; collaborate with Senior Manager, Drug Safety Operations.
- Oversee internal Drug Safety deviations and non-compliance events.
- Provide oversight of vendor Quality Events (QEs): notification, classification, investigation, and CAPA development (IDEAYA/GVP/contractual expectations).
- Lead review/governance of root cause analyses and CAPAs for vendor QEs; ensure adequacy, timeliness, and effectiveness.
- Trend/analyze deviations, QEs, and CAPAs to identify recurring/systemic risks and drive risk-based escalation/mitigation.
- Define, implement, and oversee Drug Safety compliance metrics and KPIs.
- Support preparation for regulatory inspections and internal audits; serve as compliance subject matter expert and support evidence generation.
- Support development/review/tracking of inspection responses, commitments, and post-inspection remediation.
Qualifications
- Bachelor’s degree in life sciences, pharmacy, nursing, public health, or related discipline.
- 4+ years of experience in pharmacovigilance, Drug Safety, or a related regulated environment.
Required/Preferred Skills
- Working knowledge of Drug Safety regulatory requirements.
- Experience supporting SOPs, compliance activities, and/or quality processes.
- Exposure to vendor-supported/outsourced service models.
- Strong documentation, analytical, and organizational skills; attention to detail.
- Ability to identify risks and escalate issues appropriately; risk awareness and sound judgment.
- Experience supporting audits/inspections.
- Familiarity with Safety Data Exchange Agreements (SDEAs).
- Experience working with quality/compliance systems.
- Experience collaborating with IT/system owners on compliance topics.
- Compliance-focused mindset.
- Cross-functional collaboration; ability to influence without direct authority.
Application Instructions
- N/A
We are seeking a Drug Safety Manager, Compliance and Vendor oversight who supports oversight of IDEAYA’s Drug Safety activities to ensure adherence to internal SOPs, contractual obligations, and applicable global regulatory requirements. The role provides independent compliance and system oversight for Drug Safety activities performed internally and by pharmacovigilance vendors under Safety Data Exchange Agreements (SDEAs). It does not perform case processing or system administration; it focuses on monitoring controls, identifying risks, supporting remediation, and maintaining inspection readiness.
Responsibilities
- Oversee compliance of Drug Safety activities with IDEAYA SOPs, work instructions, and applicable regulatory requirements.
- Monitor consistency of Drug Safety execution across internal teams and vendors; identify gaps and escalate with documentation and recommendations.
- Support governance and lifecycle management of Drug Safety SOPs/work instructions; ensure procedures remain current and inspection ready.
- Support SOP training/retraining and effectiveness checks for internal staff and applicable vendor personnel; assess alignment between procedures and operational practice.
- Provide consistent compliance oversight across pharmacovigilance vendors; support oversight of SDEAs (roles, responsibilities, data exchange requirements, escalation pathways).
- Monitor vendor compliance with timelines, data quality, and documentation requirements using metrics and oversight reviews.
- Collaborate with GxP IT to oversee vendor-used systems (access controls/reviews, business continuity & disaster recovery, data protection); review vendor documentation/evidence.
- Document, escalate, and track remediation of vendor/system gaps or risks; collaborate with Senior Manager, Drug Safety Operations.
- Oversee internal Drug Safety deviations and non-compliance events.
- Provide oversight of vendor Quality Events (QEs): notification, classification, investigation, and CAPA development (IDEAYA/GVP/contractual expectations).
- Lead review/governance of root cause analyses and CAPAs for vendor QEs; ensure adequacy, timeliness, and effectiveness.
- Trend/analyze deviations, QEs, and CAPAs to identify recurring/systemic risks and drive risk-based escalation/mitigation.
- Define, implement, and oversee Drug Safety compliance metrics and KPIs.
- Support preparation for regulatory inspections and internal audits; serve as compliance subject matter expert and support evidence generation.
- Support development/review/tracking of inspection responses, commitments, and post-inspection remediation.
Qualifications
- Bachelor’s degree in life sciences, pharmacy, nursing, public health, or related discipline.
- 4+ years of experience in pharmacovigilance, Drug Safety, or a related regulated environment.
Required/Preferred Skills
- Working knowledge of Drug Safety regulatory requirements.
- Experience supporting SOPs, compliance activities, and/or quality processes.
- Exposure to vendor-supported/outsourced service models.
- Strong documentation, analytical, and organizational skills; attention to detail.
- Ability to identify risks and escalate issues appropriately; risk awareness and sound judgment.
- Experience supporting audits/inspections.
- Familiarity with Safety Data Exchange Agreements (SDEAs).
- Experience working with quality/compliance systems.
- Experience collaborating with IT/system owners on compliance topics.
- Compliance-focused mindset.
- Cross-functional collaboration; ability to influence without direct authority.
Application Instructions
- N/A