Senior Director, Head of Pharmacovigilance Operations

Nurix•Brisbane, CA

15h•$288,100 - $325,700•Hybrid

About The Position

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.

Requirements

Bachelor's degree in Life Sciences, Pharmacy, Nursing, or a related field required.
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.

Nice To Haves

An advanced degree (PharmD, MS, PhD, MBA) is preferred.

Responsibilities

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.