Senior Medical Director, Pharmacovigilance & Safety (Remote)

Oruka Therapeutics Inc; Waltham (MA); Hybrid; USD 306,000 - 343,000; Full time

Benefits offered by this job

Equity

Performance bonus

Remote or hybrid work model

Job summary

Oruka Therapeutics Inc is seeking a Senior Medical Director, Pharmacovigilance and Safety to lead medical safety oversight for investigational products. The role includes governance of PV vendors, safety data analyses, and ensuring compliance with global regulations.

You will collaborate with cross-functional teams, contribute to safety regulatory documents, and shape Oruka’s PV strategy as the portfolio advances toward registration.

Qualifications

• Medical degree (MD/DO or equivalent) with completed residency.
• Minimum of 6 years of safety experience in the pharmaceutical industry.
• Strong expertise in global pharmacovigilance regulations and requirements.

Responsibilities

• Lead product safety surveillance strategies and risk-mitigation.
• Oversee expedited safety reporting and medical review of safety data.
• Provide safety input to clinical development plans and regulatory documents.
• Represent Pharmacovigilance in interactions with FDA and global authorities.
• Build and improve the pharmacovigilance infrastructure and vendor relationships.

Skills

Leadership

Communication

Analytical skills

Global pharmacovigilance

Education

MD/DO or equivalent

Tools

Argus

MedDRA

Veeva Vault

Job description

Oruka Therapeutics Inc is seeking a Senior Medical Director, Pharmacovigilance and Safety to lead medical safety oversight for investigational products. The role includes governance of PV vendors, safety data analyses, and ensuring compliance with global regulations.

You will collaborate with cross-functional teams, contribute to safety regulatory documents, and shape Oruka’s PV strategy as the portfolio advances toward registration.