Executive Director, Pharmacovigilance Quality, Inspection, Standards, Systems and Training

About Us 

Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world. It is our mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve. 

At Kardigan, we are motivated by our values which guide how we work, interact, and achieve our goals. Driven by patients and their families, we are deeply committed to improving the lives of patients and prioritizing their needs above all else. We believe in being authentic—leading with truth to bring out the best in others by creating an environment where every person knows they will be fully accepted. With an eagerness to learn, we encourage the highest levels of curiosity and are open to changing our minds. We are committed to winning as a team with urgency, excellence, and intention, and support each other no matter what role we play or where we sit. Lastly, we strive to enable the impossible because patients are counting on us. We are not afraid to take risks to unlock innovation and advance scientific discoveries.   

These values are the foundation of our work, empowering us to make a real difference, every day.  

Position Title: Executive Director, Pharmacovigilance Quality, Inspection, Standards, Systems and Training 

Department: Development 

Reports To: Head of Pharmacovigilance 

Job Overview 

The Executive Director, Pharmacovigilance Quality, Inspection, Standards, Systems and Training is responsible for establishing and leading the Company’s Pharmacovigilance Quality, Inspection, Standards, Systems and Training function: creating and managing the Company’s PV Quality Management System, writing procedural documents related to PV activities, supporting audits and inspections, providing ownership of PV systems, supporting to vendor oversight, contract review, creating training curriculum and supporting preparation and delivery of training materials; in accordance with ICH regulations and applicable regulatory requirements worldwide. 

Essential Duties and Responsibilities 

• Build and lead the PV Quality, Inspection-readiness, Standards, Systems and Training function 
• Responsible for creating, executing and overseeing global PV compliance, PV quality oversight for operational of the global Quality Management System (QMS) including Deviations, CAPAs, and performance indicators/metrics. Create and analyze oversight metrics reports, review, approve, and trend late case investigations. 
• Supports vendor oversight and management for all outsourced and/or insourced PV activities. Establish and monitor key quality and compliance metrics. 
• Develop and implement a PV inspection readiness program with the contribution of other PV and non-PV stakeholders; in collaboration with the company Quality Organization. 
• Builds and implements pharmacovigilance systems fully compliant with the applicable worldwide Health Authority PV regulations. Ensures that the PV Database supports the department needs, including specific workflows and reporting/querying functionalities. 
• Identifies immediately deviations and applicable corrective and preventive actions to maintain the compliance to reporting at its highest level. 
• Contributes to, drafts and implements department SOPs, work instructions and training materials related to the PV activities. 
• Provides expert guidance and leadership both internally and externally based on in-depth knowledge of development and post-marketing safety requirements, per ICH; US and international regulations and guidelines; and Good Pharmacovigilance Practice (GVP). 
• Develop and maintain relationships across the company particularly in functions such as clinical development/operations, clinical data management, clinical supply, manufacturing, commercial, regulatory affairs, quality, vendor/external contracts/finance, medical affairs, and other functions as appropriate to ensure compliance with PV risk management measures and ensure an integrated PV system. 

Qualifications and Preferred Skills 

• Bachelor’s degree in life sciences, pharmacy, nursing or equivalent health experience, advanced Life Sciences Degree or MBA preferred 
• 8+ years of experience in Pharmacovigilance – Quality Monitoring, Compliance, Standards field.  
• Experience with quality management system implementation. 
• Experience with safety database implementation is preferred. Experience with ARGUS and/or ArisG preferred.  
• 5+ years people management experience 
• Ability to articulate and execute the strategic vision for the pharmacovigilance department, aligning with the organization’s objectives and the evolving regulatory environment. 
• Demonstrated excellence in drug safety and pharmacovigilance practices. 
• Demonstrated understanding of applicable ICH guidelines and regulations (US, EU). 
• Ability to work with cross-functional teams. 
• Excellent oral and written communication skills. 
• Must thrive working in a fast growing/evolving, innovative environment while remaining flexible, proactive, resourceful and efficient.   
• Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations.   
• Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.