Drug SafetyIndividual Case Safety Report ManagementPharmacovigilance Operations
Useful technologies
ArgusE2B
Required qualifications
CertificationsBachelor’s Degree
Field of studyLife Sciences, Nursing, Pharmacy (or related)
Preferred qualifications
CertificationsPharmD
Original posting
Senior Director, Head of Pharmacovigilance Operations
Build and lead the pharmacovigilance operations that carry Nurix's growing clinical portfolio toward commercialization. You'll own the end-to-end ICSR model, safety systems, vendor oversight, and inspection readiness, with the chance to set strategy while staying hands-on and to build the function and team from the ground up.
Position Description
The Opportunity
Report to the Head of PV and define and execute the short- and long-term PVO strategy, goals, and operating model in alignment with the PV department and corporate objectives
Grow, mentor, and develop the PVO team, setting priorities and ensuring coverage across a growing portfolio; partner with the Head of PV on departmental planning, headcount, and budget
Provide PVO updates and escalate risks, issues, and compliance trends to PV and executive leadership as appropriate
Oversee the end-to-end ICSR management framework (intake, processing, in-stream quality review, regulatory submission oversight, and retrospective quality review), ensuring timeliness, accuracy, and compliance with global regulations (21 CFR, EU GVP, ICH E2 series)
Define, monitor, and report case processing metrics (KPIs/KQIs), drive root cause analysis and resolution of quality or timeliness issues, and oversee the drug safety mailbox
Oversee SAE reconciliation with Clinical Operations and Data Management and Reference Safety Information (RSI) tracking and dissemination, and ensure PVO input into the safety content of clinical documents (protocols, ICFs, IBs/RSI, and CSRs)
Ensure the integrity of safety data outputs from the Global Safety Database for aggregate reports, signal assessments, health authority requests, and other safety needs
Oversee operational delivery of aggregate safety reports (e.g., DSUR, PBRER/PSUR), and partner with Medical Safety, Regulatory Affairs, and Biostatistics to support signal management and benefit-risk evaluation
Own the strategy, validation, and lifecycle management of the Global Safety Database (e.g., Argus or equivalent) and related PV systems, including configuration, upgrades, and E2B gateway/electronic submission
Lead system selection, implementation, and transition projects, including safety database migrations and vendor changes, and drive automation and process improvements such as reconciliation tools, intake portals, and reporting and analytics capabilities
Lead oversight of outsourced PV activities and the CROs and vendors that support them, establishing governance, KPIs/KQIs, scorecards, and performance reviews, and driving corrective actions when performance falls short
Own PV budget planning, forecasting, and invoice review, identifying opportunities for cost optimization without compromising compliance
Lead the strategy and management of PV Agreements and Safety Data Exchange Agreements (SDEAs) with license partners, collaborators, and distributors
Own PVO inspection readiness and launch readiness, and lead PVO participation in internal audits, vendor audits, and regulatory inspections, including front-room/back-room support and CAPA development and tracking through closure
Develop, maintain, and continuously improve PVO and compliance-related SOPs, work instructions, and process documentation, and monitor the evolving global regulatory landscape so PVO processes adapt to new requirements
Act as the senior PVO liaison to Clinical Operations, Data Management, Regulatory Affairs, Quality, Biostatistics, and Medical Safety, and support PV input into due diligence, in-licensing, and business development activities as needed
What You’ll Bring
Bachelor's degree in Life Sciences, Pharmacy, Nursing, or a related field required; an advanced degree (PharmD, MS, PhD, MBA) is preferred
Minimum of 12 years of pharmacovigilance/drug safety experience in biotech or pharma, including in a leadership role managing PV operations and people
Deep experience in PV operations and ICSR management across clinical development, with commercial readiness experience
Demonstrated experience building, scaling, or transforming PV operations, ideally in a growing biotech environment
Significant experience managing PV vendors and CROs, including KPI/KQI development, governance, and performance management
Experience owning PV budgets, forecasting, and invoicing
Experience leading or substantially supporting regulatory inspections and audits (FDA, EMA, or other health authorities), including CAPA management
Experience with safety database implementations, upgrades, or transitions
Proven experience authoring and governing SOPs, work instructions, and quality system documentation
Experience negotiating and managing PVAs/SDEAs with license partners
Strong leadership, coaching, and talent development skills, with the ability to build high-performing teams
Excellent communication and influencing skills, with the ability to work effectively with executive leadership and cross-functional partners
Strong analytical, organizational, and project management skills, with the ability to manage multiple products and priorities at once
Quality and compliance mindset with strong attention to detail
Comfort operating in a fast-paced, evolving environment, including through organizational change
Salary Range: $ $288,100 - $325,700
The posted range applies to roles based in the San Francisco Bay Area and reflects local market conditions. Where an offer lands within that range depends on the candidate’s relevant experience, technical expertise, and how their background aligns with the role’s requirements.
Location: Remote or Onsite – Brisbane, CA
Fit with Nurix Culture and Values
Strong team orientation; highly collaborative
Solutions and results-oriented focus
Hands-on approach; resourceful and open to diverse points of view
About Nurix Therapeutics
Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.