Sr Manager, Kite Safety and Pharmacovigilance

Employer
Kite Pharma
Location
Santa Monica, CA, United States
Posted
Sep 13, 2020
Ref
R0015338
Required Education
Bachelors Degree
Position Type
Full time
Kite is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job

Job Description

The Senior Manager, Kite Safety and Pharmacovigilance is responsible for and supports various pharmacovigilance activities for Kite's investigational and marketed products.

NOTE: This position can located in Santa Monica, CA (highly preferred) or remote.

Responsibilities:
  • Lead cross functional team and author periodic safety reports (PSUR, PADER, DSUR, etc)
  • Support signal detection, evaluation and management activities including chairing meetings, and preparing/archiving meeting minutes
  • Author and co-author with Safety Physician safety reviews for signal detection
  • Support development and maintenance of core and local labels for Kite products (CCDS, USPI, SmPC, etc)
  • Participate in marketing application and filing activities
  • Serve as the PV Science Safety representative for Kite clinical trials including eTMF activities
  • Assist in initiation and updates of partner PV agreements and CRO safety reporting agreements
  • Participate in authoring responses to safety-related requests from health authorities
  • Collaborate with Biostatistics and Safety Physician for data retrieval and analysis for clinical trial oversight committees
  • Provide safety content and review of clinical protocols, clinical summary reports, and informed consent forms
  • Monitor literature for potential safety signals; participate and contribute to cross functional initiatives to improve literature surveillance
  • Perform all activities in accordance with Kite and Gilead SOP/WRKs and regulatory requirements


Requirements :
  • BS/BA with 8+ years of direct Pharmacovigilance Science experience - OR - MS/MA or MBA with 6+ years of direct Pharmacovigilance Science experience - OR - PhD with 4+ years of direct Pharmacovigilance Science experience
  • Excellent knowledge of FDA, EMA, and ICH safety reporting regulations and GVP guidelines
  • Experience with using safety database (Argus), MedDRA, and WHO Drug
  • Strong quality focus, with a good understanding of quality systems
  • Excellent communicator, both oral and written, specifically medical writing skills
  • Ability to critically analyze individual and aggregate safety data with scientific rigor
  • Experience in preparing periodic safety reports and authoring safety reviews
  • Strong relationship building skills, with ability to interact effectively in a multifunctional and multicultural team setting
  • Excellent written and verbal communication skills to a variety of levels and teams, internally and externally
  • Demonstrated persuasion, influencing and negotiation skills
  • Ability to operate objectively and independently as a leader and as a member of a team, as required
  • Effective team player, with proven ability to effectively lead projects and teams to successful conclusion


Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.

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For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.