Director, Drug Safety & Pharmacovigilance Operations

Director, Drug Safety & Pharmacovigilance Operations The Director, Drug Safety & Pharmacovigilance (DSPV) Operations, serves as a senior operational leader and subject matter expert for safety activities across Rigel’s portfolio. The Director is accountable for the strategy, execution, governance, and continuous improvement of global pharmacovigilance operations supporting clinical development and marketed products. This is an individual-contributor role with no direct reports; the Director leads through functional ownership, cross-functional influence, and vendor governance. The role works hands‑on across functions and oversee third‑party vendors to ensure timely, accurate, scalable, and compliant safety data collection, case processing, reporting, and documentation in accordance with DSPV procedures, industry standards, and applicable global regulations. The Director provides end-to-end leadership of ICSR management, safety data exchange and reconciliation, vendor performance, safety systems, quality and compliance, inspection readiness, resource planning, and operational risk management. The Director advises senior leadership on emerging risks, capacity needs, performance trends, and strategic priorities. Regular onsite presence is required to support cross‑functional collaboration, team engagement, and business operations. Employees designated as onsite or hybrid who reside within the local commuting area are expected to work onsite at Rigel’s South San Francisco headquarters during normal business hours each Wednesday and Thursday. Employees designated as remote are expected to work onsite during normal business hours for a minimum of two Wednesday/Thursday business‑day periods per month, as scheduled with management, and more frequently as business needs require.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Leadership and Cross‑Functional Partnership Provide hands‑on functional leadership for DSPV Operations activities; establish priorities, coordinate cross‑functional contributors and vendor resources, and drive execution across competing program needs. Serve as the senior DSPV Operations liaison to cross‑functional program and clinical teams, governance bodies, and external partners; provide strategic and practical safety‑operations guidance and communicate risks, priorities, recommendations, and decisions. Build effective partnerships with Clinical, Regulatory, Quality, Medical, Legal, Finance, Procurement, IT, and other functions to align safety strategy, operating models, resources, and program needs. Prepare and present safety operations strategies, performance trends, risks, and recommendations to senior leadership, governance forums, cross‑functional teams, and external partners. Safety Data Management and Reporting Establish and lead the global operating model for safety data collection and processing across clinical trial and postmarketing programs, with accountability for quality, compliance, scalability, and timely delivery. Direct end‑to‑end ICSR operations, including intake/triage, follow‑up, data entry, coding, quality review, medical review workflow, expedited submission, case closure, and reconciliation; establish controls and escalation pathways for critical issues. Ensure effective quality oversight of serious adverse events and expedited reports, including narrative accuracy, MedDRA coding, source‑document consistency, follow‑up queries, and documented remediation of recurring trends. Provide operational leadership and ensure cross‑functional delivery of aggregate and summary safety reports, including IND Annual Reports, DSURs, PSURs/PBRERs, PADERs, integrated safety summaries, and related safety sections of protocols, CSRs, and regulatory submissions. Own the reconciliation framework for safety data across clinical, safety, partner, and other relevant systems; ensure discrepancies, trends, and systemic issues are resolved, documented, and escalated appropriately. Direct study and program safety set‑up, including Safety Management Plans, reporting conventions, reconciliation plans, oversight models, and study‑specific safety requirements. Quality, Compliance, and Inspection Readiness Maintain authoritative knowledge of adverse event reporting requirements, pharmacovigilance regulations, and safety systems; lead the development, approval, and lifecycle management of SOPs, work instructions, and safety management documents. Establish and oversee a risk‑based compliance framework covering regulations, PV agreements, internal procedures, training requirements, documentation standards, and reporting timelines. Own DSPV Operations inspection readiness; lead operational support for internal audits and global regulatory inspections, coordinate responses to findings, and ensure timely and sustainable remediation. Provide leadership and final operational oversight for PV deviations, investigations, root‑cause analyses, CAPAs, and effectiveness checks; elevate material compliance risks to senior leadership. Define and govern operational quality and compliance metrics (e.g., KPIs, KRIs/KQIs, submission timeliness, case quality, reconciliation status); interpret trends and drive remediation, investment decisions, and continuous improvement. Signal Detection and Risk Management Ensure robust operational support and cross‑functional execution for signal detection, safety surveillance, benefit‑risk, and risk‑management activities. Partner with Safety Science and Medical functions on evaluation of complex safety data and potential signals; ensure timely trend analyses, similar‑event analyses, governance documentation, and safety‑topic tracking. Support development and maintenance of Risk Management Plans (RMPs), REMS, and other risk‑minimization activities, as applicable. Vendor, Alliance, and Business Management Set the outsourcing strategy and provide accountable sponsor oversight of pharmacovigilance vendors supporting clinical and postmarketing safety activities, including outsourced case processing and specialized services. Chair or lead vendor governance and establish performance frameworks, including KPIs/SLAs, quality monitoring, executive reviews, issue escalation, action tracking, remediation, and continuous improvement plans. Ensure compliant and timely safety data exchange with business partners and vendors; lead operational strategy, negotiation, implementation, and maintenance of PVAs/SDEAs and related procedures. Lead operational input to vendor selection and qualification, audits, governance meetings, remediation, and training on Rigel products and program requirements. Own safety‑operations budget planning and vendor financial oversight, including forecasts, SOWs/change orders, contract negotiations, invoice review, cost controls, and resource scenarios in partnership with Finance, Legal, and Procurement. Safety Systems and Technology Serve as business owner or senior operational lead for the safety database and related systems; define the roadmap and govern access, configuration changes, controlled terminology, data outputs, upgrades, validation/UAT, and vendor‑hosted environments, as applicable. Direct E2B(R2/R3) electronic safety reporting and gateway strategy and operations; partner with vendors and IT to ensure compliant implementation, monitoring, issue resolution, and business continuity. Ensure effective business continuity and disaster‑recovery planning and sponsor compliant automation, analytics, and process‑standardization initiatives aligned with the DSPV technology roadmap. Complex Problem Solving and Innovation Apply broad drug‑safety and business expertise to make sound decisions on complex, ambiguous, and time‑sensitive operational issues; proactively identify enterprise and portfolio risks and mitigation strategies. Sponsor and lead scalable, innovative approaches that strengthen safety monitoring, compliance, quality, organizational capability, and operational efficiency; establish change‑management and adoption plans.…

KNOWLEDGE AND SKILL REQUIREMENTS:

Bachelor’s degree in nursing, pharmacy, life sciences, another healthcare‑related field, or equivalent qualification/work experience. Minimum 10 years of progressively responsible pharmaceutical/biotechnology Drug Safety/Pharmacovigilance experience or equivalent, including responsibility for complex PV Operations programs, vendor models, and cross‑functional initiatives. Minimum 5 years managing third‑party PV vendors/CROs, outsourced operating models, and business alliance relationships. Demonstrated experience leading cross‑functional initiatives and outsourced vendor teams in a matrixed environment; direct people‑management experience is not required. Demonstrated experience leading end‑to‑end global pharmacovigilance operations across clinical development and postmarketing settings, including outsourced and partner‑supported operating models. Preferred Qualifications Global pharmacovigilance operations leadership across development and commercial products, with expert knowledge of ICH, FDA, EMA, GVP, and applicable clinical and postmarketing reporting requirements. Experience with safety databases, MedDRA coding, data entry/review, aggregate reporting, and regulatory safety submissions. Experience with validated PV systems (e.g., Oracle Argus Safety, ARISg, or comparable), including outputs, system changes/UAT, and vendor‑hosted environments. Working knowledge of ICH E2B(R2/R3), electronic expedited reporting, MedDRA, and WHO Drug coding conventions. Experience developing/managing PVAs/SDEAs, Safety Management Plans, reconciliation plans, vendor oversight plans, and operational metrics/KPIs. Experience with deviations, CAPAs, audits, inspections, and inspection‑readiness activities in a GVP‑regulated environment. Experience with safety signal detection and benefit‑risk assessment; experience interfacing with regulatory authorities on safety matters preferred. Strong strategic, analytical, financial, and organizational judgment; ability to prioritize across a portfolio, make risk‑based decisions, and deliver through competing timelines. Executive‑level written, verbal, technical communication, and presentation skills, including the ability to translate complex safety issues into clear decisions and influence senior stakeholders. Proven ability to lead in a fast‑paced, cross‑functional, matrixed environment, influence stakeholders at all levels, and drive accountability without direct authority. Experience with vendor financial management, business continuity, system implementation/upgrades, validation/UAT, or process automation is preferred.

COMPENSATION AND BENEFITS:

The anticipated salary range for this position is National $210,000 to $250,000. The actual salary offered will depend on several factors, including experience, qualifications, geographic location, internal equity, and business needs. This position is eligible to participate in Rigel's annual bonus program and is eligible for equity incentive awards, subject to the terms of the applicable plans. This position is not commission-based. Rigel offers eligible employees a comprehensive benefits package, including medical, dental, and vision coverage; life and disability insurance; flexible spending accounts; a 401(k) plan; paid time off; paid company holidays; and other benefits.

WORKING CONDITIONS:

PHYSICAL DEMANDS: While performing the duties of this job, the employee is required to stand, walk; sit; talk and hear. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and the ability to adjust focus. WORK ENVIRONMENT: The noise level in the work environment is usually moderate. Some travel may be required. Rigel Pharmaceuticals, Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law. #J-18808-Ljbffr Rigel Pharmaceuticals