Senior Director, Medical Safety & Pharmacovigilance
$351.18k - $409.71kCytokinetics
Cytokinetics seeks a Senior Director to lead global pharmacovigilance and medical safety strategy for its cardiovascular drug pipeline. The role oversees safety assessment, regulatory compliance, signal detection, and risk management across investigational and marketed products, managing a team of safety professionals.
Responsibilities
- Provide strategic medical leadership for global safety surveillance and risk management across all product development stages
- Lead development and implementation of pharmacovigilance policies, procedures, and governance processes
- Direct signal detection and management activities, including evaluation and communication of emerging safety signals
- Oversee medical review of serious adverse events and individual case safety reports for regulatory compliance
- Chair safety governance forums and lead escalation of significant safety issues
Requirements
- MD, MD/PhD, or MD/MPH degree
- 12+ years pharmaceutical industry experience in drug development and safety leadership
- Deep knowledge of FDA, EMA, ICH, and global pharmacovigilance regulations
- Demonstrated experience managing safety surveillance and signal detection activities
- Proven leadership managing teams and influencing cross-functional stakeholders
- Strong clinical judgment and ability to communicate benefit-risk assessments
Compensation: $351,180-$409,710 base salary
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