Senior Medical Director, Pharmacovigilance and Safety

Oruka Therapeutics

. Develop and lead product safety surveillance strategies .

Posted 9/25/2026full-timeWaltham • Massachusetts • United StatesSenior💰 $306,000 - $343,000 per yearWebsite

Tech Stack

Tools & technologies

Vault

About the role

Key responsibilities & impact

Develop and lead product safety surveillance strategies
Identify emerging clinical safety issues and recommend risk-mitigation measures
Conduct or oversee routine and ad hoc safety-data reviews and monitor safety signals
Lead aggregate safety reviews and chair internal safety governance committees
Plan, interpret, prepare, and present safety-data analyses and summaries
Build relationships with clinical study teams, safety vendors, and business partners
Oversee expedited safety reporting, including medical review of ICSRs, SUSARs, and other reportable safety events
Ensure medical follow-up and consistent assessment of individual safety cases
Review clinical-trial safety data and provide medical safety guidance
Lead aggregate reporting and prepare regulatory documents, including Investigator's Brochures, DSURs, and Risk Management Plans
Provide safety input into clinical development plans, protocols, consent forms, case report forms, statistical analysis plans, data-monitoring plans, and clinical study reports
Represent Pharmacovigilance in meetings with the FDA and other global regulatory authorities
Maintain compliance with global pharmacovigilance regulations, SOPs, and internal guidelines
Build and improve Oruka’s pharmacovigilance system and infrastructure
Oversee vendors supporting case processing, safety-database management, aggregate reporting, and literature surveillance
Monitor vendor quality and performance and resolve issues
Provide safety leadership for independent data monitoring and adjudication committees
Support inspection readiness and represent Pharmacovigilance during inspections, audits, and due-diligence activities

Requirements

What you’ll need

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

Comp & perks

Competitive base salary
Equity
Performance-related bonus opportunity
Competitive salary and benefits package
Opportunities for professional growth and development
Supportive and inclusive team environment
Startup culture where work can directly impact bringing new medicines to patients