Director, Pharmacovigilance & Oncology Safety Strategy

Rigel Pharmaceuticals, Inc.; South San Francisco (CA); On-site; USD 265,000 - 310,000; Full time

Benefits offered by this job

Bonus program and equity incentives

Comprehensive medical/dental/vision

401(k) retirement plan and generousP托

Paid time off and holidays

Job summary

Rigel Pharmaceuticals, Inc. is seeking a Director of Pharmacovigilance to lead drug safety across development and marketed products.

You will define safety strategy, governance, medical oversight, and compliance while guiding cross-functional teams and external partners from Rigel's South San Francisco headquarters. The role requires an MD with 10+ years in pharmacovigilance, strong oncology experience, and proven leadership.

Qualifications

• MD required; active U.S. medical license preferred.
• Minimum 10 years of progressive drug safety and pharmacovigilance experience in the biopharmaceutical industry.
• Minimum 4 years in leadership roles with drug safety team-management and/or functional-leadership responsibility.
• Demonstrated expertise in oncology drug development and precision medicine approaches.
• Experience with novel therapeutic modalities including targeted therapies and biomarker-driven development.
• Deep knowledge of global pharmacovigilance regulations (ICH, FDA, EMA, GVP) and precision medicine guidance.
• Extensive experience with regulatory submissions for complex oncology products.
• Advanced expertise in safety signal detection methodologies and benefit-risk assessment frameworks.
• Experience integrating biomarker data into safety monitoring and risk management strategies.
• Proven ability to influence and collaborate with cross-functional stakeholders.
• Excellent written and verbal communication skills with ability to present complex safety concepts.
• Demonstrated experience interfacing with regulatory authorities on safety matters and leading inspection or audit readiness activities.
• Previous biotech/pharmaceutical industry experience with marketed products, as well as demonstrated ability to lead and develop staff and external safety partners.

Responsibilities

• Own the Pharmacovigilance operating model, including strategic planning, policies, procedures, systems, quality metrics, and continuous process improvement.
• Establish and lead safety governance, including escalation and resolution of significant safety issues, benefit-risk positions, and risk-management recommendations.
• Provide medical and scientific oversight of safety assessments, including individual and aggregate safety data, emerging signals, and product risk profiles.
• Lead and develop Pharmacovigilance staff and provide directional oversight to external service providers and CRO partners.
• Own vendor governance, including service delivery, performance management, compliance, and issue escalation.
• Lead inspection and audit readiness for Pharmacovigilance activities, including investigation, remediation, and CAPA oversight.
• Oversee business partner relationships, including attendance at Joint Steering Committee meetings and construction of Pharmacovigilance Agreements.
• Oversee medical review of aggregate safety data in regulatory reports to ensure balanced, medically sound presentation.
• Oversee medical review of Individual Case Safety Reports (ICSRs) including causality, seriousness, and coding quality.
• Oversee preparation, review, and timely submission of expedited and periodic safety reports, aggregates, and safety content for protocols and regulatory submissions.
• Lead set-up of new safety projects, including Safety Management Plans and safety systems.

Skills

Pharmacovigilance leadership

Oncology drug development

Regulatory submissions

Safety signal detection

Global pharmacovigilance regulations

Effective communication

Cross-functional collaboration

Medical judgment

Regulatory authority liaison

Biomarker data in safety monitoring

Education

MD

Job description

Rigel Pharmaceuticals, Inc. is seeking a Director of Pharmacovigilance to lead drug safety across development and marketed products.

You will define safety strategy, governance, medical oversight, and compliance while guiding cross-functional teams and external partners from Rigel's South San Francisco headquarters. The role requires an MD with 10+ years in pharmacovigilance, strong oncology experience, and proven leadership.