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Director, Pharmacovigilance

Employer
Kezar Life Sciences
Location
South San Francisco, California
Start date
Oct 2, 2022

View more

Discipline
Clinical, Drug Safety/Pharmacovigilance
Required Education
Doctorate/PHD/MD
Position Type
Full time
Hotbed
Biotech Bay
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Job Details

Kezar Life Sciences (NASDAQ: KZR), a clinical-stage biotechnology sciences company located in South San Francisco, is seeking a Director, Pharmacovigilance. This role will report to the Head of Clinical Science.

Kezar is focused on small molecule drug discovery and development to target immune-mediated diseases and cancer. Kezar’s lead product candidate, KZR-616, a selective inhibitor of the immunoproteasome, is being evaluated in Phase 2 clinical trials for the treatment of severe autoimmune diseases. KZR-261, Kezar’s first oncology candidate targeting the protein secretion pathway via the Sec61 translocon, is now being studied in a Phase 1 clinical trial in several oncology indications.


RESPONSIBILITIES

  • Responsible and accountable for developing PV systems, CRO relationship/process improvement, outsourced activities, and deliverables related to PV
  • Provide strong medical writing/review support for drug safety sections of protocols, ICFs, IBs, CSRs, and other documents, including safety management plans and aggregate safety reports [e.g., DSURs, Annual Reports, etc.]
  • Develop Drug Safety Standard Operating Procedures
  • Conduct adverse event, literature, and other safety-relevant data analysis for the purpose of signal detection
  • Evaluate and lead implementation, if applicable, of a safety database, including informing on configuration and validation
  • Review standard design of tables, figures, and listings for safety data from clinical studies, including coding review
  • Assist in the formation of an appropriate safety governance structure processes to provide CRO oversight and be a partner in the identification, assessment, and communication of potential safety signals
  • Collaborate with Regulatory Affairs, Clinical, and Quality to ensure appropriate reporting of PV and drug safety information and help inform risk mitigation measures that achieve the expected risk management outcomes
  • Monitor industry best practices and changes in global safety regulations and guidelines
  • Contribute to preparation and quality control activities for key safety documents
  • Collaborate with a team of professionals who provide safety monitoring support for ongoing clinical trials
  • Coordinate responses and resolutions to safety questions from regulatory authorities, as well as regulatory agency audits and inspections and corrective action plans

REQUIREMENTS

  • Advanced degree (MD, DO, Ph.D., RN or PharmD preferred)
  • Minimum 6+ years of Pharmacovigilance/drug safety/drug development experience in the biopharmaceutical industry
  • Proficiency in strategizing, planning, monitoring, and problem-solving
  • Excellent strategic thinking skills, with demonstrated ability to successfully create and implement both short- and long-term plans to support the direction of the function and the organization
  • Flexibility to work in a fast-paced environment
  • Ability to manage multiple and diverse issues
  • Strong facilitation, organizational, analytical, and time management skills


Kezar Life Sciences is an Equal Opportunity Employer

#LI-DNI

Company

Founded in 2015 and based in South San Francisco, Kezar (pronounced “keys are”) Life Sciences is combining courage, conviction and cutting-edge science to develop breakthrough treatments for immune-mediated and oncologic disorders – with the hope of helping people overcome their disease and live a better life. We are pioneering first-in-class, small molecule therapies that harness master regulators of cellular function to inhibit multiple drivers of disease via single, powerful targets. We are translating our innovative research in protein degradation (via immunoproteasome inhibition) and protein secretion (via the Sec61 translocon) to have a significant clinical impact in the most difficult-to-treat diseases.

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Stock Symbol: $KZR

Find Us
Website
Phone
650-822-5600
Location
4000 Shoreline Ct
Suite 300
South San Francisco
94080
United States
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