Global Safety & Pharmacovigilance Director

Cytokinetics, Inc.; United States; On-site; USD 351,000 - 410,000; Full time

Benefits offered by this job

Stock options/RSUs

Health insurance

401k with employer match

Paid time off

Learning and wellness stipends

Job summary

Cytokinetics, Inc. in South San Francisco, CA seeks a Senior Director, Medical Safety & Pharmacovigilance to lead global safety strategy for investigational and marketed products, oversee PV staff, and ensure rigorous risk management across the product lifecycle.

The role partners with Clinical Development, Regulatory Affairs, Medical Affairs, and external partners to maintain regulatory compliance and high-quality safety communications.

Qualifications

• MD/DO required with 12+ years in pharma, including pharmacovigilance leadership.
• Deep understanding of global PV regulations (FDA, EMA, ICH).
• Proven leadership in safety surveillance, signal management, and aggregate reporting.
• Strong communication skills with experience presenting to senior leadership.

Responsibilities

• Provide strategic leadership for global safety surveillance and risk management across all products.
• Develop and improve PV policies, procedures, and safety governance processes.
• Ensure global PV regulatory compliance and reporting requirements.
• Lead signal detection, evaluation, and communication of safety signals.
• Oversee medical review of serious adverse events and safety reports.
• Chair Safety Management Team meetings and drive timely safety decisions.
• Prepare safety assessments, benefit-risk evaluations, and regulatory safety submissions.
• Oversee core safety documents and safety data exchange with partners.
• Collaborate with Clinical Development, Regulatory Affairs, Medical Affairs, and vendors to integrate safety perspectives.

Skills

MD

Pharmacovigilance leadership

Regulatory compliance

Team leadership

Cross-functional collaboration

Education

MD/DO

Job description

Cytokinetics, Inc. in South San Francisco, CA seeks a Senior Director, Medical Safety & Pharmacovigilance to lead global safety strategy for investigational and marketed products, oversee PV staff, and ensure rigorous risk management across the product lifecycle.

The role partners with Clinical Development, Regulatory Affairs, Medical Affairs, and external partners to maintain regulatory compliance and high-quality safety communications.