Director, Kite Safety and Pharmacovigilance (PV)

职位描述

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