Director of Pharmacovigilance and Safety

The Kyverna Pharmacovigilance and Drug Safety Team (PVPS) 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 Director of PVPS, working alongside the VP of PVPS , will lead the development and implementation of safety strategies including signal detection, safety surveillance, work with internal teams and provide vendor management oversight, oversight of internal and external compliance metrics, and ensure the timely delivery of safety reports for health authorities, including aggregate reports. The Director of PVPS must be able to lead, strategize and execute, as well as, be accountable and responsible for day-to-day safety work deliverables.

Reports to: Head of Global Safety and Pharmacovigilance

Location: Remote

Responsibilities

• Lead day-to-day pharmacovigilance activities, including regulatory reporting, safety assessments, and responding to regulatory inquiries.
• Perform signal detection and manage safety data using tools such as Excel, PowerPoint, Tableau, and other relevant software.
• Work with pharmacovigilance vendors to generate and maintain safety listings from the Safety Database.
• Communicate and collaborate with cross-functional teams, including legal, regulatory, clinical development, clinical operations, and biostatistics.
• Leverage medical expertise to assess safety data from various sources (e.g., toxicology, pre-clinical, clinical, post-approval, literature).
• Prepare and deliver presentations on safety concerns and risk management evaluations to internal stakeholders.
• Manage and oversee literature reviews for investigational and marketed products.
• Coordinate and contribute to drafting, reviewing, and submitting periodic safety reports (e.g., DSUR, PADER, PBRER), ensuring accuracy and completeness.
• Author and review safety sections of regulatory documents such as investigator brochures (IBs), clinical trial protocols, informed consent forms (ICFs), clinical report forms (CRFs), and product labels (e.g., package inserts, CCDS).
• Collaborate with Medical Writers and Biometrics teams to plan and review safety content for clinical study reports (CSRs) and other submission documents (e.g., summary of safety module 2.7.4).
• Coordinate the writing of safety narratives for completed clinical trials with the Medical Writing team or contractors.
• Prepare, author, and review safety content for core and regional Risk Management Plans (RMPs) and pharmacovigilance plans for BLA submissions.
• Ensure compliance with global regulatory requirements, including collaborating with EU colleagues to meet regional requirements.
• Schedule, host, and prepare materials for DSC meetings, both scheduled and ad-hoc.
• Develop, implement, and support pharmacovigilance policies, SOPs, work instructions (WIs), templates, and forms; contribute to process improvements across functions.
• Participate in audit preparedness activities and serve as a subject matter expert during regulatory inspections.
• Ensure global regulatory compliance for all Serious Adverse Events (SAEs), signal management, risk management, and other pharmacovigilance activities.
• Other responsibilities as assigned.

Requirements

• Bachelor’s degree and 10+ years of experience in pharmacovigilance; or Advanced degree (Master’s degree in a health-related field) and 6+ years of experience in pharmacovigilance
• 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
• Experience in overseeing vendors, monitoring compliance metrics, critical thinking, problem solving, excellent written and verbal skills, and superior organization skills highly desirable.
• 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 Pharmacovigilance and Safety in building out a global PV organization. 
• Strong computer and database skills (Excel, PowerPoint, Word)

The salary range for this position is from $205,000  - $245,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position, and the actual salary may vary based on various factors, including without limitation individual education, experience, tenure, skills and abilities, as well as internal equity and alignment with market data.  This position is also eligible for bonus, benefits, and participation in Company’s stock option plan.