Senior Medical Director, PV & Safety (Remote)

Openkrill; United States; Hybrid; USD 306,000 - 343,000; Full time

Job summary

Oruka Therapeutics seeks a Senior Medical Director, Pharmacovigilance and Safety to provide medical safety oversight for investigational products and to lead safety governance across development programs. The role combines clinical judgment with pharmacovigilance expertise in a growing biotech setting.

The position requires a MD/DO with at least 6 years of pharmacovigilance experience, strong regulatory knowledge, and the ability to guide cross-functional teams, vendors, and regulators in a

Qualifications

• MD/DO or equivalent with completed residency.
• 6+ years of safety experience in 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)
• Ability to work effectively in a dynamic, cross-functional, and fast-paced team environment.
• Excellent communication, leadership, and analytical skills.

Responsibilities

• Provide medical safety oversight for investigational products and lead safety activities.
• Oversee pharmacovigilance vendors and risk management processes.
• Prepare regulatory safety documents and conduct safety data reviews.
• Collaborate with FDA and global regulators and study teams.
• Help build pharmacovigilance infrastructure, governance, and vendor partnerships.

Skills

MD/DO or equivalent

6+ years safety experience

Global pharmacovigilance knowledge

Cross-functional teamwork

Safety systems (Argus, MedDRA, Veeva)

Leadership and communication

Education

Medical degree (MD/DO)

Tools

Argus

MedDRA

Veeva Vault

Job description

Oruka Therapeutics seeks a Senior Medical Director, Pharmacovigilance and Safety to provide medical safety oversight for investigational products and to lead safety governance across development programs. The role combines clinical judgment with pharmacovigilance expertise in a growing biotech setting.

The position requires a MD/DO with at least 6 years of pharmacovigilance experience, strong regulatory knowledge, and the ability to guide cross-functional teams, vendors, and regulators in a