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Senior Director, Pharmacovigilance and Safety Leadership
2 months ago
Kyverna Therapeutics, Inc. is seeking a highly experienced Senior Director, Pharmacovigilance and Safety Leadership to join our team. As a key member of our organization, you will be responsible for developing and implementing robust pharmacovigilance strategies, ensuring regulatory compliance, and providing expert oversight of safety assessment and signal management activities.
Key Responsibilities- Pharmacovigilance Leadership: Develop and execute a strategic vision for the Pharmacovigilance department, aligning with the company's objectives and industry best practices.
- Safety Surveillance and Risk Management: Oversee the collection, evaluation, and analysis of safety data from clinical trials, post-marketing sources, and other relevant sources.
- Signal Detection and Benefit-Risk Assessment: Lead signal detection activities, identifying emerging safety signals and potential trends in collaboration with cross-functional teams.
- 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.
- Quality and Compliance: Ensure compliance with global pharmacovigilance regulations and guidelines, and drive the development and maintenance of pharmacovigilance SOPs and processes.
- 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.
