Senior Director Pharmacovigilance

Kyverna Therapeutics; United States; Remote; USD 265,000 - 310,000; Full time

Benefits offered by this job

Bonus

Benefits

Stock Option Plan

Job summary

An established industry player is seeking a Senior Director of Pharmacovigilance and Patient Safety to lead their global safety strategy. This role involves overseeing the PVPS team, managing vendor relationships, and ensuring compliance with safety regulations. The ideal candidate will possess extensive experience in pharmacovigilance, strong leadership skills, and the ability to collaborate across various departments. Join a forward-thinking organization that values innovation and teamwork, and play a crucial role in maintaining the safety and efficacy of their products in the market. This is an exciting opportunity to drive impactful initiatives in a dynamic environment.

Qualifications

• 15+ years of experience in pharmacovigilance or 12+ years with an advanced degree.
• Strong leadership skills and extensive knowledge of safety reporting requirements.

Responsibilities

• Define and oversee strategic direction and operations of the PVPS group.
• Manage vendor relationships and ensure compliance with service agreements.
• Provide oversight for product safety deliverables and regulatory filings.

Skills

Pharmacovigilance

Leadership

Signal Detection

Problem Solving

Communication Skills

Critical Thinking

Project Management

Education

Bachelor's Degree in Health-related Field

Master's Degree in Health-related Field

Tools

Argus

Excel

PowerPoint

Word

Job description

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.

Reports to: Head of Global Safety and Pharmacovigilance

Location: Remote

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.

The salary range for this position is from $265,000 - $310,000 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.

Seniority level

• Director

Employment type

• Full-time

Job function

• Research, Analyst, and Information Technology
• Industries: Biotechnology Research, Research Services, and Pharmaceutical Manufacturing