Senior Medical Director, Pharmacovigilance and Safety

Job Title:  Senior Medical Director, Pharmacovigilance and Safety        

Location: Remote or Hybrid if located near Waltham, MA office and will be required to be in-office in 3 days/week.          

Role Overview:

Oruka is seeking an experienced, collaborative pharmacovigilance leader to provide medical and scientific safety oversight for Oruka’s investigational products. The Senior Medical Director, Pharmacovigilance and Safety will lead safety activities and processes, oversee Oruka’s pharmacovigilance vendors, and ensure continuous assessment of each product's safety profile and benefit-risk balance. This role will also serve as the medical safety expert on cross-functional development teams, working closely with internal and external stakeholders to ensure compliance with regulations and guidelines, contribute to safety regulatory documents, and protect participant safety.

The successful candidate will combine strong clinical judgment and pharmacovigilance expertise with a team-oriented approach suited to a growing biotechnology company. The role will also help develop Oruka’s pharmacovigilance infrastructure, processes, governance, and vendor partnerships as the portfolio advances through clinical development and toward registration.

Key Responsibilities: 

Product Safety Leadership and Risk Management

• Develop and lead product safety surveillance strategies, identify emerging clinical safety issues, and recommend appropriate risk-mitigation measures.
• Conduct or oversee routine and ad hoc reviews of safety data, monitor for safety signals, and maintain awareness of relevant drug-class and competitor safety issues.
• Lead ongoing aggregate safety review and chair internal safety governance committees.
• Plan and interpret safety data analyses; prepare and present safety data summaries to internal and external stakeholders.
• Build effective working relationships with clinical study teams, safety vendors, and business partners to align on product safety strategy.

Medical Safety Oversight

• Oversee expedited safety reporting, including medical review of Individual Case Safety Reports (ICSRs), suspected unexpected serious adverse reactions (SUSARs), and other reportable safety events.
• Ensure appropriate medical follow-up and consistent medical assessment of individual safety cases.
• Provide medical review of clinical trial safety data, including adverse events, laboratory results, vital signs, ECGs, exposure data, and relevant nonclinical or external information.
• Provide medical safety guidance to investigators, study teams, and internal stakeholders.

Clinical Development and Regulatory Support

• Lead safety-related aggregate reporting and the preparation and maintenance of relevant sections of Investigator's Brochures, including Reference Safety Information, Development Safety Update Reports, Risk Management Plans, and other regulatory documents.
• Provide safety input into clinical development plans, study protocols, informed consent forms, case report forms, statistical analysis plans, data-monitoring plans, and clinical study reports.
• Represent Pharmacovigilance in correspondence and meetings with the FDA and other global regulatory authorities.
• Maintain current knowledge of global pharmacovigilance regulations and guidance and ensure activities comply with applicable requirements, standard operating procedures, and other internal guidelines. 

Pharmacovigilance Infrastructure and External Partnerships

• Help build and continuously improve Oruka’s pharmacovigilance system as the company and clinical portfolio grow.
• Oversee pharmacovigilance vendors supporting case processing, safety-database management, aggregate reporting, and literature surveillance.
• Set clear vendor expectations, monitor quality and performance, and ensure timely resolution of issues
• Provide safety leadership for independent data monitoring committees and adjudication committees, including development of charters, data-review plans, meeting materials, and recommendations.
• Support inspection readiness and represent Pharmacovigilance during regulatory inspections, audits, and due-diligence activities. 

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)
• Ability to work effectively in a dynamic, cross-functional, and fast-paced team environment.
• Excellent communication, leadership, and analytical skills.

Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for candidates, who will work remotely or Waltham, MA is $306,000 to $343,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states. If candidate is remote travel expectation will be up to 20% of the time.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.