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Director, Kite Safety and Pharmacovigilance (PV)

United States – RemotePharmacovigilance & EpidemiologyRegular

Arbeitsbeschreibung

Director, Kite Safety and Pharmacovigilance (PV), under the guidance of the Executive Director of PV Science, is responsible for overseeing signal detection and safety governance activities, writing periodic/aggregate reports for
Kite investigational and marketed products, and managing clinical trial support activities for Kite. The candidate should also be prepared to be a key representative for audits and inspections for quality and compliance.


Responsibilities:

  • Based on extensive prior experience, oversee and author periodic safety reports in accordance with standard procedures and global regulatory requirements
  • Manage complex timelines to achieve on time completion with cross-functional collaboration and delivery of key documents (Reference Safety Information, Marketing Application components, etc.)
  • Author and review safety assessments and mentor team members on effective signal evaluation methods and rigorous scientific analysis
  • Contribute to core and local safety documents for Kite products (CCDS, USPI, SmPC, IB, etc.)
  • Prepare responses to safety related requests from health authorities
  • Provide safety content review of clinical protocols, CSRs, SAPs, and ICFs
  • Liaise with cross functional teams from Kite and Gilead
  • Manage direct report full time employees or vendors/contractors
  • Support and initiate educational training for Kite personnel in Safety and PV principles and practices
  • Oversee and participate in representing PV Science deliverables for PV audits and inspections
  • Monitor industry best practices and regulatory guidance and lead continuous process improvement related to PV Science activities
  • Recruit, hire, and provide line management/leadership to members of the PV Science team
  • Anticipate and assess future business needs with succession plans for PV Science team within cell therapy


Basic Qualifications:

  • MS/MA in life sciences, biology, medical or pharmacy-related and 10+ years of experience in pharmacovigilance OR
  • PharmD or PhD in life sciences, biology or related field and 2+ years of experience in pharmacovigilance


Preferred Qualifications:

  • PharmD or PhD in life sciences, biology or related field and 6+ years of experience in pharmacovigilance
  • Solid knowledge of FDA, EMA, and ICH and GVP guidelines.
  • Experienced in using safety databases: Rave, Argus, MedDRA, and WHO Drug
  • Strong quality focus, with a good understanding of quality systems and compliance
  • Excellent communicator in presentations and written reports; medical writing skills

Experience, Skills, Knowledge:

  • Ability to critically analyze individual and aggregate safety data with scientific rigor
  • Extensive experience in signal detection, analysis, and management
  • Extensive experience in preparing global periodic safety reports, including strategizing and developing responses to questions from Health Authorities