Senior Medical Director, Pharmacovigilance and Safety

The role

The Senior Medical Director, Pharmacovigilance and Safety will provide medical and scientific safety oversight for investigational products. This person will lead safety activities, oversee pharmacovigilance vendors, and ensure the safety profile and benefit-risk balance of products.

What you will do

• Develop and lead product safety surveillance strategies
• Conduct or oversee routine and ad hoc reviews of safety data
• Lead ongoing aggregate safety review and chair internal safety governance committees
• Plan and interpret safety data analyses
• Oversee expedited safety reporting and medical review of ICSRs and SUSARs
• Provide medical review of clinical trial safety data
• Provide medical safety guidance to investigators and study teams
• Lead safety-related aggregate reporting and preparation of regulatory documents
• Provide safety input into clinical development plans and protocols
• Represent Pharmacovigilance in meetings with global regulatory authorities

Required qualifications

• Medical degree (MD/DO or equivalent) with completed residency
• Minimum of 6 years of safety experience within the pharmaceutical industry
• Strong expertise in global pharmacovigilance regulations and requirements
• Demonstrated ability to work effectively in a dynamic, cross-functional, and fast-paced team environment
• Proficient with safety surveillance systems and tools (e.g., Argus, MedDRA, Veeva Vault)
• Excellent communication, leadership, and analytical skills

Benefits

• Competitive salary and benefits package
• Vibrant startup culture
• Supportive and inclusive team environment
• Opportunities for professional growth and development

About the company

Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. The company is advancing a proprietary portfolio of antibodies targeting plaque psoriasis and other dermatologic and inflammatory diseases.