Senior Manager, Drug Safety Operations

IDEAYA Biosciences • South San Francisco, CA

7d • $184,000 - $227,000 • Hybrid

About The Position

IDEAYA is a precision medicine oncology company committed 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, or 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. When you're at IDEAYA, you will be in the midst of brilliant minds working on precision medicine therapies to help cancer patients. We are passionate and committed about being on the forefront of oncology medicine, which means we all have a high internal drive that is at the very core of every person at IDEAYA. We are inquisitive, ask deep questions, and are data-driven innovators who like to collaborate and use team work to move science forward. For more information, please see www.ideayabio.com.

We are seeking a Senior Manager, Drug Safety Operations, to join IDEAYA as the operational leader for Individual Case Safety Report (ICSR) management. As Senior Manager, Drug Safety Operations, you will serve as 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, who retains primary responsibility for PV system compliance and governance. This position is based in our South San Francisco headquarter offices and required to be onsite four days per week per our company policy.

Requirements

• Bachelor’s degree in life sciences, health sciences, pharmacy, nursing, or a related discipline 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.
• Employees must demonstrate good judgement and ethical behavior in all business activities, maintain patient and product safety as a top priority, and report any suspected violations of law or Company policy through appropriate channels
• This position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for medical or religious reasons, and/or as otherwise required by applicable law.
• The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.
• At IDEAYA we believe in the importance of on-site presence by all team members as an essential ingredient to effective collaboration.
• Our hybrid approach to work at IDEAYA includes all staff being on-site four days per week in the office, and one day per week working from home.

Nice To Haves

• Advanced degree (Master’s, PharmD, RN) preferred but not required

Responsibilities

• 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 Safety Data base 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 appropriately 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.

Benefits

• Along with our inspiring mission, and highly collaborative and inclusive environment, IDEAYA offers a competitive total rewards package that reflects our pay-for-performance philosophy where employees are eligible to be considered for merit-based salary increases, company discretionary short-term incentive plan participation, and company discretionary stock option awards (based on board approval).
• Our comprehensive benefits package includes, but is not limited to, medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents), 401k, ESPP, and wellness programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 101-250 employees