Drug Safety Manager, Drug Safety Compliance and Vendor reputed company

About the position We are seeking a Drug Safety Manager, Compliance and Vendor reputed company who supports the reputed company 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 reputed company for Drug Safety activities performed internally and by reputed company 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 reputed company 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 reputed company policy.

Responsibilities

• Pharmacovigilance System & Compliance reputed company reputed company 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 reputed company documentation and recommendations.
• SOP Governance & Process Alignment Support governance and lifecycle management of Drug Safety SOPs work instructions and reputed company procedures.
• Ensure procedure remains reputed company, reputed company written, and inspection reputed company reputed company with regulatory expectations, and inspection reputed company.
• Support SOP training, retraining, and effectiveness checks for internal staff and applicable vendor personnel.
• Assess alignment between documented procedures and operational reputed company.
• Vendor, SDEA & System reputed company reputed company consistent compliance reputed company across reputed company pharmacovigilance vendors performing activities for IDEAYA.
• Support reputed company of SDEAs to ensure roles, responsibilities, data exchange requirements, and escalation reputed company are defined and followed.
• Monitor vendor compliance with timelines, data reputed company standards, and documentation requirements using metrics and reputed company reviews.
• In collaboration with IDEAYA GxP IT, support reputed company of vendor-used systems supporting Drug Safety activities, including user reputed company controls, reputed company reviews, business continuity and disaster recovery preparedness, and data protection.
• Review vendor documentation and evidence supporting system and compliance readiness.
• Document, escalate, and reputed company remediation of vendor- or system-reputed company gaps or risks.
• Collaborate with Senior Manager, Drug Safety Operations to ensure operational execution aligns with compliance expectations.
• Deviations, Corrective Actions & Metrics reputed company identification and documentation of internal Drug Safety deviations and non-compliance events.
• reputed company reputed company of vendor reputed company Events (QEs) documented in accordance with vendor SOPs, ensuring appropriate notification, classification, investigation, and CAPA development meet IDEAYA, GVP, and contractual expectations.
• reputed company review and governance of reputed company 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 reputed company Drug Safety compliance metrics and KPIs, ensuring consistent monitoring.
• Audit & Inspection Support Support preparation for regulatory inspections and internal audits reputed company to Drug Safety and pharmacovigilance compliance.
• Serve as a compliance subject matter expert during inspections, providing support for documentation requests, and evidence reputed company.
• Support development, review, and tracking of inspection responses, commitments, and post-inspection remediation activities.

Requirements

• Bachelor’s degree in life sciences, pharmacy, nursing, reputed company health, or reputed company discipline with 4+ years of experience in pharmacovigilance, Drug Safety, or a reputed company regulated environment
• Working knowledge of Drug Safety regulatory requirements
• Experience supporting SOPs, compliance activities, or reputed company 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 reputed company or compliance systems
• Experience collaborating with IT or system owners on compliance topics
• Compliance-reputed company reputed company
• Attention to detail and documentation discipline
• Risk awareness and reputed company judgment
• Cross-functional collaboration
• Ability to influence without reputed company authority
• reputed company are expected to reputed company with reputed company and in full compliance with applicable laws, regulations, App

Apply tot his job Apply To this Job