Senior Medical Director, Pharmacovigilance and Safety

Role: Senior Medical Director, Pharmacovigilance and Safety, overseeing safety strategies for Oruka’s investigational biologics targeting chronic skin diseases like psoriasis. Responsibilities include developing safety surveillance plans, leading safety data reviews, managing risk mitigation, medical oversight of safety reporting, and contributing to regulatory documents. The role also involves building pharmacovigilance infrastructure, vendor oversight, and representing safety in regulatory interactions. Requirements: MD/DO with at least 6 years of pharma safety experience, strong knowledge of global pharmacovigilance regulations, proficiency with safety systems (e.g., Argus, MedDRA, Veeva Vault), and excellent communication skills. Preferred: experience in biologics or dermatology therapies, familiarity with clinical trial safety data, and vendor management. High-value: biologics for dermatologic indications, clinical development, global pharmacovigilance compliance, vendor oversight, and regulatory reporting. Work setup: remote or hybrid near Waltham, MA, with up to 20% travel.