[Hiring] Executive Director, Safety & Pharmacovigilance @Kyverna Therapeutics
Role Description
The Executive Director of Safety & Pharmacovigilance (PV) will play a key role in the global safety strategy and execution for the Company’s cell therapy pipeline across clinical development and post-marketing activities. This role is responsible for leading a compliant, scalable safety organization, ensuring proactive risk management, regulatory compliance, and cross-functional collaboration to support clinical and regulatory milestones.
• Define and lead the global safety and pharmacovigilance strategy across all development stages.
• Serve as the safety subject-matter expert for cell therapy programs, including novel and emerging safety risks.
• Provide strategic safety input to clinical development plans, protocols, investigator brochures, and regulatory submissions.
• Act as a key member of cross-functional governance and program teams.
• Oversee all PV activities including case processing, signal detection, risk management, and aggregate reporting.
• Ensure compliant execution of ICSR reporting, DSURs, PBRERs/PSURs, SUSARs, and safety narratives.
• In collaboration with other team members, maintain safety databases, vendor oversight, and PV agreements (SDEAs).
• Lead safety surveillance activities and ongoing benefit-risk assessments.
• Review and approve safety data, medical assessments, and regulatory safety documents.
• Contribute to Safety Review Committees (SRCs), Data Monitoring Committees (DMCs), and internal safety governance forums.
• Lead safety signal evaluation, escalation, and documentation.
• Ensure compliance with global safety regulations (FDA, EMA, ICH, CIOMS, local health authorities).
• Partner with team lead for regulatory interactions, inspections, and audits.
• Author or oversee safety sections of INDs and BLAs, and responses to health authority inquiries.
• Partner with team members to maintain PV SOPs, processes, and inspection readiness.
• Lead development and lifecycle management of Risk Management Plans (RMPs) and REMS, as applicable.
• Proactively identify and mitigate safety risks associated with cell therapy modalities.
• Support post-marketing safety planning and launch readiness, where applicable.
• Collaborate in the management of external vendors, CROs, and safety service providers.
• Contribute to the operational excellence, continuous improvement, and cost-effective PV operations.
Qualifications
• MD degree
• 12+ years of experience in pharmacovigilance and drug safety, with at least 5 years in a leadership role.
• Direct experience supporting cell therapy, gene therapy, or other advanced modalities strongly preferred.
• Experience in clinical-stage biotech; prior BLA/MAA and/or launch experience is a plus.
• Demonstrated success interacting with global regulatory agencies on safety matters.
• Strong knowledge of global PV regulations and safety standards.
• Strategic thinker with the ability to operate hands-on in a lean organization.
• Excellent cross-functional leadership and communication skills.
• Proven ability to balance compliance, scientific rigor, and business priorities.
Requirements
• The national base salary range for this position is $365K-$390K annually.
• This salary range is an estimate of what we reasonably expect to pay for this position, and the actual salary may vary based on various factors that may include but are not limited to quality and length of experience, education, geographic location and alignment with market data.
• This position is also eligible for bonus, benefits, and participation in the company’s stock plan.
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The Executive Director of Safety & Pharmacovigilance (PV) will play a key role in the global safety strategy and execution for the Company’s cell therapy pipeline across clinical development and post-marketing activities. This role is responsible for leading a compliant, scalable safety organization, ensuring proactive risk management, regulatory compliance, and cross-functional collaboration to support clinical and regulatory milestones.
• Define and lead the global safety and pharmacovigilance strategy across all development stages.
• Serve as the safety subject-matter expert for cell therapy programs, including novel and emerging safety risks.
• Provide strategic safety input to clinical development plans, protocols, investigator brochures, and regulatory submissions.
• Act as a key member of cross-functional governance and program teams.
• Oversee all PV activities including case processing, signal detection, risk management, and aggregate reporting.
• Ensure compliant execution of ICSR reporting, DSURs, PBRERs/PSURs, SUSARs, and safety narratives.
• In collaboration with other team members, maintain safety databases, vendor oversight, and PV agreements (SDEAs).
• Lead safety surveillance activities and ongoing benefit-risk assessments.
• Review and approve safety data, medical assessments, and regulatory safety documents.
• Contribute to Safety Review Committees (SRCs), Data Monitoring Committees (DMCs), and internal safety governance forums.
• Lead safety signal evaluation, escalation, and documentation.
• Ensure compliance with global safety regulations (FDA, EMA, ICH, CIOMS, local health authorities).
• Partner with team lead for regulatory interactions, inspections, and audits.
• Author or oversee safety sections of INDs and BLAs, and responses to health authority inquiries.
• Partner with team members to maintain PV SOPs, processes, and inspection readiness.
• Lead development and lifecycle management of Risk Management Plans (RMPs) and REMS, as applicable.
• Proactively identify and mitigate safety risks associated with cell therapy modalities.
• Support post-marketing safety planning and launch readiness, where applicable.
• Collaborate in the management of external vendors, CROs, and safety service providers.
• Contribute to the operational excellence, continuous improvement, and cost-effective PV operations.
Qualifications
• MD degree
• 12+ years of experience in pharmacovigilance and drug safety, with at least 5 years in a leadership role.
• Direct experience supporting cell therapy, gene therapy, or other advanced modalities strongly preferred.
• Experience in clinical-stage biotech; prior BLA/MAA and/or launch experience is a plus.
• Demonstrated success interacting with global regulatory agencies on safety matters.
• Strong knowledge of global PV regulations and safety standards.
• Strategic thinker with the ability to operate hands-on in a lean organization.
• Excellent cross-functional leadership and communication skills.
• Proven ability to balance compliance, scientific rigor, and business priorities.
Requirements
• The national base salary range for this position is $365K-$390K annually.
• This salary range is an estimate of what we reasonably expect to pay for this position, and the actual salary may vary based on various factors that may include but are not limited to quality and length of experience, education, geographic location and alignment with market data.
• This position is also eligible for bonus, benefits, and participation in the company’s stock plan.
Apply tot his job
Apply To this Job