The Kyverna Pharmacovigilance and Patient Safety (PVPS) Team serves as the pharmacovigilance experts for all Kyverna products globally and are accountable for the safety strategy and major safety deliverables for all Kyverna products, in clinical trial development and marketed. The Senior Director of Pharmacovigilance and Patient Safety will support internal stakeholders including Clinical Operations, Medical Affairs, Clinical Development, and Regulatory Affairs on matters of patient/subject safety. The Senior Director of Pharmacovigilance and Safety will require a deep understanding of pharmacovigilance regulatory requirements, product safety issues, safety operational support, strong vendor management oversight, understanding of compliance metrics, providing strategic input on all things safety, and the ability to work with the VP Pharmacovigilance and Drug Safety to build out a global PV organization.

Responsibilities

• Define and oversee the strategic direction and day-to-day operations of the PVPS group, including case processing, product safety reviews, and updates to critical safety documents (ICF, IB, protocol, RMP, labeling) in collaboration with the VP of PVPS.
• Lead the development and implementation of internal processes, including SOPs, WIs, and policies.
• Manage the PVPS budget in partnership with the VP of PVPS.
• Oversee vendor management for PV vendors, ensuring adherence to service agreements and performance metrics.
• Develop and maintain the training matrix for PVPS staff and other Kyverna employees in conjunction with the VP of PVPS.
• Provide oversight for product safety deliverables, including routine and ad hoc safety outputs, global regulatory filing documents, and safety plans (e.g., ISS/SAP, labeling, REMS).
• Ensure Kyverna’s inspection readiness by supporting PV inspections and audits (internal and external), serving as a subject matter expert during regulatory inspections.
• Lead data migration efforts.
• Collaborate on developing signal detection strategy, forms, outputs, and data assessments with the VP of PVPS and other team members.
• Prepare presentations as needed.
• Manage risk management plans (RMPs) and other risk-related documents for Kyverna products.
• Evaluate adverse event (AE) reports for safety issues and set signal detection strategy for all Kyverna molecules.
• Act as the Subject Matter Expert (SME) for Individual Case Safety Report (ICSR) processing.
• Assist in building out the EU and ROW PV organization with the VP of PVPS.
• Drive process improvements and assess, communicate, and implement initiatives with the VP of PVPS.
• Provide oversight for vendors when creating aggregate reports (e.g., PADERS, DSURs, PSURs).
• Respond to requests from health authorities in a timely manner with the VP of PVPS.
• Oversee the safety setup for new clinical trials, including preparation of study-specific SAE processing documents and safety sections of protocols, ICFs, and IBs.
• Represent the DS team on cross-functional safety and alliance teams.

Requirements

• Bachelor’s degree and 15+ years of experience in pharmacovigilance; or Advanced degree (master’s degree in health-related field) and 12+ years of experience in pharmacovigilance/drug safety.
• Strong leadership skills in leading teams, complex projects, and working on strategic initiatives within PVPS and cross functional teams.
• Extensive knowledge and understanding of US and international safety reporting and pharmacovigilance requirements and signal detection (e.g., FDA and EU regulations, and guidance documents)
• Knowledge of working with a safety database (i.e., Argus) for retrieval of safety information
• Strong computer and database skills (Excel, PowerPoint, Word)
• Must be able to work independently, as well as work in a fast-paced, collaborative environment and work across other functional groups at Kyverna. Also, must be able to multi-task, prioritize competing assignments, easily communicate complex issues, and assist the VP of PVPS in building out a global PV organization.
• Skilled in critical thinking, problem solving, excellent written and verbal skills, superior understanding of businesses processes, strong presentation skills, and superior organizational skills