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Oruka Therapeutics
Salary Distribution
3 of 3 jobs
Open Positions
Lead product safety surveillance strategies and risk management for investigational products. Oversee medical review of safety data and ensure compliance with global pharmacovigilance regulations. Build pharmacovigilance infrastructure and manage vendor partnerships as the company grows.
Pharmacovigilance
Regulatory Compliance
Supports clinical trial design, protocol development, and data interpretation to ensure high-quality data generation. Provides medical expertise in therapeutic areas, reviews safety data, and contributes to regulatory documents. Collaborates cross-functionally with clinical operations, regulatory affairs, and other teams to align clinical activities with development plans.
Clinical Development
Clinical Trial Design
GCP
Regulatory Affairs
Leadership
Collects, reviews, and analyzes adverse event reports from clinical trials to identify potential safety signals. Supports the preparation and review of pharmacovigilance documents such as DSURs, dRMPs, and relevant clinical trial sections. Collaborates with cross-functional teams including clinical operations, regulatory affairs, and medical affairs.
Pharmacovigilance
Regulatory Compliance
Clinical Trials