Kyverna Therapeutics
Associate Director, Safety and Pharmacovigilance
Emeryville, CA · Director
Sponsorship not specified$170k-$200kDetected 43 days ago
PharmacologyPharmacovigilanceCollaborationPublic SpeakingOrganizational SkillsEpidemiology
About the role
- Join us at the forefront of cell therapy innovation and help redefine what's possible.
- The individual will contribute across case/vendor oversight, compliance, signal management, aggregate reporting, and benefit-risk evaluation.
- The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties.
Responsibilities
- Develop and maintain an expert understanding of the latest safety regulations, technology, and safety profile of the assigned product(s) as well as understanding of the relevant strategic context (e.g., disease indication, safety profile of competitors, mechanism of action)
- Manage and support the relationship with safety vendors to ensure effectiveness, quality and compliance of all outsourced activities in collaboration with Director of PV operations.
- Lead oversight of quality and key performance indicators (case processing and aggregate reports) and present findings to Head of PV and relevant cross-functional stakeholders.
- Ensure operational outputs support high-quality scientific safety assessment
- Lead signal detection and management activities, including literature search, data analyses, preparation of safety data for cross-functional safety team meetings, and drafting presentations and regulatory responses, in collaboration and consultation with the safety physician.
- Lead the drafting of safety sections of IB, aggregate reports (e.g. PADERs, PSURs, PBRERs, DSURs), and Risk Management Plans etc., in collaboration and consultation of the safety team and the cross-functional teams.
- Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases.
Requirements
- Minimum 8 years of experience working within Pharmacovigilance, experience with both PV operations and clinical safety/safety science (e.g., signal detection, risk management, regulatory responses) required
- Advanced knowledge of safety databases (i.e., Argus), MedDRA coding, signal detection, aggregate reports, and RMPs required
- Education
- Bachelor's Degree in a scientific, life sciences, or medical field
- Experience
- Advanced knowledge of Working Group, Code of Federal Regulations, International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH)
Nice to have
- advanced degree in life science, epidemiology, or (certification/licensure) in Nursing or pharmacology preferred
- Experience with neurology or autoimmune diseases preferred
- Understanding of how AI can be applied in Pharmacovigilance is a plus
Skills
- Advanced knowledge of Good Pharmacovigilance Practices - both U.S. and European Regulations and Directives, CIOMS/MedWatch
- Excellent ability to analyze and effectively communicate product safety information
- Demonstrates an attention to detail, results oriented, and good organizational skills
- Self-motivated with the ability to work both independently and collaboratively within a team environment
- Ability to adapt quickly to a changing business environment
- The national salary range for this position is from $170K to $200K USD annually.
- This position is also eligible for bonus, benefits, and participation in Company's stock plan.
Compensation
- The national salary range for this position is from $170K to $200K USD annually.
Benefits
- Support and contribute to global regulatory submissions (e.g. drafting response to Health Authority requests, authoring and reviewing submission packages, etc.) with the safety team and the cross-functional experts.
- Bachelor's Degree in a scientific, life sciences, or medical field; advanced degree in life science, epidemiology, or (certification/licensure) in Nursing or pharmacology preferred
Company info
- Guided by our core values, Stay True to Why, Collaborate to Accelerate, Lead with Clarity, Boldly Innovative, and Own the Outcome, we are committed to transforming the future of treatment for autoimmune disease.
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