Senior Manager, Drug Safety Operations

Job Summary IDEAYA is a precision medicine oncology company dedicated to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small‑molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first‑in‑class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody‑drug conjugates (ADCs) for molecularly defined solid tumor indications. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer. Position Summary We are seeking a Senior Manager, Drug Safety Operations to serve as the operational leader for Individual Case Safety Report (ICSR) management. As Senior Manager, Drug Safety Operations you will be the day‑to‑day operational lead and subject‑matter expert for ICSR execution across the development portfolio, working within the strategic and governance framework established by the Director of Safety Operations. This role focuses on operational excellence, vendor performance and case quality, with awareness of regulatory requirements and active collaboration with the Drug Safety Manager, Compliance and Vendor oversight. The position is based in our South San Francisco headquarters and requires being onsite four days per week in accordance with company policy. What you’ll do Lead ICSR Operations & Quality 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. Drive Vendor Excellence (Operational Oversight) 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 the Safety Database 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. PSMF Establishment & Operational Support 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 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. Audit & Inspection Support (ICSR Operations) 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. Cross‑Functional Collaboration 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. Requirements Bachelor’s degree in life sciences, health sciences, pharmacy, nursing or a related discipline required. Advanced degree (Master’s, PharmD, RN) preferred but not 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. All employees are expected to act with integrity and in full compliance with applicable laws, regulations and IDEAYA policies, including IDEAYA’s Code of Conduct. Total Rewards IDEAYA offers a competitive total rewards package that reflects our pay‑for‑performance philosophy. Employees are eligible for merit‑based salary increases, a company discretionary short‑term incentive plan and company discretionary stock option awards (approved by the board). The comprehensive benefits package includes medical, dental and vision coverage (100% company paid for employees and 90% company paid for dependents), a 401(k) plan, an employee share purchase plan and wellness programs. The expected salary range for this Senior Manager, Drug Safety Operations role is $184,000 – $227,000, with the final offer depending on factors such as location, experience, education and performance during the interview process. Equal Opportunity Employment IDEAYA complies with all laws respecting equal employment opportunities and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state and local law. We do not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation or any other legally protected status. EOE/AA/Vets. We are committed to providing reasonable accommodations to qualified individuals with disabilities. If you need assistance or an accommodation due to a disability, please contact us at View email address on click.appcast.io. All employees working in IDEAYA facilities are required to be fully vaccinated against COVID‑19, with the exception of accommodations for medical or religious reasons when permissible by law. Vaccination is considered complete 14 days after the second dose of a two‑dose series or after a single‑dose vaccine, with valid approval from the FDA or a WHO‑listed vaccine for those vaccinated outside the United States. #J-18808-Ljbffr BioSpace