Kyverna Therapeutics, Inc.
Senior Director, Pharmacovigilance
Kyverna Therapeutics, Inc., Emeryville, California, United States, 94608
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The Kyverna therapeutic platform leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells at the origin of autoimmune and inflammatory diseases. Be at the forefront of cell therapy innovation by joining scientists, industry veterans and healthcare visionaries and help transform how autoimmune diseases are treated.The Senior/Executive Director of Pharmacovigilance will play a pivotal role in shaping and leading our pharmacovigilance function. This role is responsible for developing and implementing robust pharmacovigilance strategies, ensuring regulatory compliance, and providing expert oversight of safety assessment and signal management activities. The ideal candidate will be a strategic thinker with a deep understanding of pharmacovigilance regulations and best practices. The successful candidate will play a critical role in ensuring the safety of our cell therapy products throughout their lifecycle and contribute to our mission of improving outcomes for patients with autoimmune diseases.Responsibilities:
Pharmacovigilance Leadership:
Develop and execute a strategic vision for the Pharmacovigilance department, aligning with the company's objectives and industry best practices.Provide subject matter expertise to internal stakeholders and ensure compliance with global pharmacovigilance regulations and guidelines.Lead and mentor a team of pharmacovigilance professionals, fostering a culture of collaboration, excellence, and continuous improvement.Safety Surveillance and Risk Management:
Oversee the collection, evaluation, and analysis of safety data from clinical trials, post-marketing sources, and other relevant sources.Lead the preparation and submission of expedited and periodic safety reports to health authorities, ensuring accuracy, completeness, and timeliness.Develop and implement risk management strategies, including REMS (Risk Evaluation and Mitigation Strategies), to minimize potential safety risks.Signal Detection and Benefit-Risk Assessment:
Lead signal detection activities, identifying emerging safety signals and potential trends in collaboration with cross-functional teams.Lead efforts to identify potential safety signals by analyzing safety data from various sources, including clinical trials, investigator-initiated trials, compassionate use programs, comparable products, and real-world evidence.Conduct comprehensive benefit-risk assessments to inform decision-making and regulatory interactions.Cross-Functional Collaboration:
Collaborate closely with Clinical Development, Regulatory Affairs, Medical Affairs, and other departments to ensure effective communication of safety information and alignment on safety strategies.Provide pharmacovigilance expertise in regulatory interactions, including Health Authority meetings and audits.Quality and Compliance:
Ensure compliance with global pharmacovigilance regulations and guidelines, and drive the development and maintenance of pharmacovigilance SOPs and processes.Lead pharmacovigilance audits and inspections, ensuring timely and accurate responses to regulatory inquiries.Prepare and submit high-quality safety reports, including periodic safety reports (PSURs/PBRERs), development safety update reports (DSURs), and ad-hoc safety communications to regulatory authorities.Requirements:
Advanced degree (Ph.D., Pharm.D., M.D., or equivalent) in a relevant scientific field.Minimum 7 – 10 years of experience in pharmacovigilance within the biopharmaceutical industry, with a strong background in cell therapies or advanced therapeutic modalities.Proven leadership experience, including managing teams and strategic oversight of pharmacovigilance activities.Demonstrated success in interacting with regulatory authorities.Deep understanding of global pharmacovigilance regulations, guidelines, and best practices.Excellent communication, collaboration, and problem-solving skills.Strong ability to work in a fast-paced, early-stage biotechnology environment, adapting to changing priorities and demands.Experience with safety databases and signal detection tools.$212,000 - $265,000 a year
Kyverna is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Kyverna is committed to the principle of equal employment opportunity for all employees and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets
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Pharmacovigilance Leadership:
Develop and execute a strategic vision for the Pharmacovigilance department, aligning with the company's objectives and industry best practices.Provide subject matter expertise to internal stakeholders and ensure compliance with global pharmacovigilance regulations and guidelines.Lead and mentor a team of pharmacovigilance professionals, fostering a culture of collaboration, excellence, and continuous improvement.Safety Surveillance and Risk Management:
Oversee the collection, evaluation, and analysis of safety data from clinical trials, post-marketing sources, and other relevant sources.Lead the preparation and submission of expedited and periodic safety reports to health authorities, ensuring accuracy, completeness, and timeliness.Develop and implement risk management strategies, including REMS (Risk Evaluation and Mitigation Strategies), to minimize potential safety risks.Signal Detection and Benefit-Risk Assessment:
Lead signal detection activities, identifying emerging safety signals and potential trends in collaboration with cross-functional teams.Lead efforts to identify potential safety signals by analyzing safety data from various sources, including clinical trials, investigator-initiated trials, compassionate use programs, comparable products, and real-world evidence.Conduct comprehensive benefit-risk assessments to inform decision-making and regulatory interactions.Cross-Functional Collaboration:
Collaborate closely with Clinical Development, Regulatory Affairs, Medical Affairs, and other departments to ensure effective communication of safety information and alignment on safety strategies.Provide pharmacovigilance expertise in regulatory interactions, including Health Authority meetings and audits.Quality and Compliance:
Ensure compliance with global pharmacovigilance regulations and guidelines, and drive the development and maintenance of pharmacovigilance SOPs and processes.Lead pharmacovigilance audits and inspections, ensuring timely and accurate responses to regulatory inquiries.Prepare and submit high-quality safety reports, including periodic safety reports (PSURs/PBRERs), development safety update reports (DSURs), and ad-hoc safety communications to regulatory authorities.Requirements:
Advanced degree (Ph.D., Pharm.D., M.D., or equivalent) in a relevant scientific field.Minimum 7 – 10 years of experience in pharmacovigilance within the biopharmaceutical industry, with a strong background in cell therapies or advanced therapeutic modalities.Proven leadership experience, including managing teams and strategic oversight of pharmacovigilance activities.Demonstrated success in interacting with regulatory authorities.Deep understanding of global pharmacovigilance regulations, guidelines, and best practices.Excellent communication, collaboration, and problem-solving skills.Strong ability to work in a fast-paced, early-stage biotechnology environment, adapting to changing priorities and demands.Experience with safety databases and signal detection tools.$212,000 - $265,000 a year
Kyverna is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Kyverna is committed to the principle of equal employment opportunity for all employees and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets
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