Associate Director, Pharmacovigilance Functional Excellence and Inspection Readiness (FEIR)

About Us 

Position Title: Associate Director, Pharmacovigilance Functional Excellence and Inspection Readiness (FEIR)

Department: Pharmacovigilance

Reports To: Senior Director, Pharmacovigilance Functional Excellence and Inspection Readiness

Location: Princeton, NJ - On-site 4 days per week (Mon to Thurs)

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 Kardigan’s mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve.

Led by Tassos Giannakakos, Jay Edelberg, M.D. and Bob McDowell, Ph.D., Kardigan’s co-founders have reunited after leading MyoKardia to discover and develop mavacamten, the first cardiac myosin inhibitor, resulting in an acquisition by Bristol Myers Squibb in 2020.

We have a cutting-edge discovery and translational research platform, a pipeline of late-stage candidates, and an industry-leading team that is driven to improve the lives of patients.

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. 

Job Overview

The Associate Director, Pharmacovigilance Functional Excellence and Inspection Readiness, will be part of the overall Kardigan PV department, where they will be responsible for creating, managing and executing of the Kardigan’s quality management system, infrastructure and staff to support the operational aspects of the PV system and adheres to all global regulatory requirements and internal processes and procedures.  The position performs multiple activities related to overall quality management systems, including quality/compliance of case management, safety computer system operations support, vendor oversight, PV compliance, PV inspection readiness, contracts and training.  In addition, this position is responsible for building and maintaining relationships with key strategic internal and external stakeholders including PV Business Partners/Vendors and adverse event reporting/PV training of company personnel and their partners.

Essential Duties and Responsibilities

• PV Case Monitoring: Responsible for monitoring ICSR to ensure timely submissions of expedited reports to the FDA & other health authorities. Identifies immediately deviations and applicable corrective and preventive actions to maintain the compliance to reporting at its highest level.
• PV Quality and Compliance Monitoring: Responsible for executing global PV compliance and PV quality oversight for operational of the global Quality Management System (QMS) including Deviations, CAPAs, and performance indicators/metrics. May also include performing QC of PV documentation to be used for external submissions such as aggregate reports, PSMF, RMP, etc.
• PV Vendor Oversight: Conducts vendor oversight and management for all outsourced and/or insourced PV activities, including establishing and monitoring key quality and compliance metrics.
• Audit and Inspection Support: Prepares for internal and third-part audits and Health Authority inspections by developing an inspection readiness strategy, SME engagement/pre-interviews, coordinating documentation staging/requests, training and other readiness activities.  Function as SME for the PV FEIR team during inspection and support inspection management and follow-up activities; in collaboration with the company Quality Organization.
• PV IT Systems and Processes: Ensures that PV requirements are built into safety IT and automation activities. Support the set-up of any new safety projects, including the set-up of safety systems and database configurations in the PV databases (safety database, signal detection/management system, safety documentation, etc.) to accommodate these trials and products.
• SOP and Quality Documentation Management: Leads the drafting, reviewing and maintaining PV department SOPs, work instructions and related materials such as training documentation.
• PV Training: Engages in the development of annual PV training, role-based training programs and materials related to PV and associated activities for internal and external staff in coordination with the company Quality Organization.
• PV Activities: Performs other tasks related to the operation of the PV QMS as assigned by manager to assist in departmental activities. Tasks include contributing to the operation and oversight of PV operations, case processing, signal detection, safety data review, benefit-risk profile assessment and aggregate reporting activities.
• Stakeholder support: Develops and maintains 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.
• Staff/Team Management: Initially functioning as an individual contributor, role may develop into managing of direct reports. May be responsible for managing internal and external staff allocated to operational PV activities, creating a highly efficient team across insourced and outsourced resources.
• In collaboration with other senior leadership, develop and implement PV operations strategy, vision, and direction, including the overall PV QMS.
• Articulate and execute the strategic vision for the PV department, aligning with the organization's objectives and the evolving regulatory environment.
• champion excellence in drug safety and PV practices throughout the company
• Provide 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).
• Represent PV on project teams, other departments, and committees as needed.

Qualifications and Preferred Skills

• Bachelor’s degree in life sciences, pharmacy, nursing or equivalent health experience, advanced Life Sciences Degree or MBA preferred
• Minimum of 5-8 years of experience in Drug Safety / Pharmacovigilance role in pharmaceutical industry; minimum 5 years in managerial role in drug safety; experience in biopharmaceuticals preferred
• Demonstrated ability to create, evaluate, and maintain effective business processes and implement procedures, systems, and tools to maximize resources within a Drug Safety department
• Through knowledge and experience in all aspects of safety reporting for clinical trials and marketed situations.
• Strong knowledge and experience with currently available drug safety database systems, document management systems and QC tools. This also includes MedDRA and linked technologies.
• Operational expertise with a leading safety database is preferred.
• Excellent oral and written communication skills
• Strong interpersonal and leadership skills and demonstrated ability to manage, motivate and influence work behaviors of individuals who are not direct reports
• 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.