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Life sciences Job USA | Manager position @ Kite Pharma

Life sciences Job USA | Manager position @ Kite Pharma

Life sciences Job USA | Manager position @ Kite Pharma: Kite Pharma is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient’s own immune system to selectively target and kill cancer cells.  Our core technology involves the genetic engineering of T cells, or white blood cells, to express either chimeric antigen receptors (CARs) or T cell receptors (TCRs) for the treatment of advanced solid and hematological malignancies.  We are on a rapid growth trajectory and have a highly energized and accomplished team. Kite is publicly traded (NASDAQ: KITE) with a current market well over $2 Billion.

Life sciences Job USA |  Manager position @ Kite Pharma

JOB DESCRIPTION

We are seeking a highly motivated individual to join us as a Manager of Pharmacovigilance Operations,  Standards and Training.  You will work with the Patient Safety team in supporting our efforts in this exciting new area of cancer immunotherapy. This role will be a hands-on resource reporting to Head of Patient Safety within Clinical Research and Development.

Responsibilities:

  • Monitor and oversee PV data collection per regulations, PV agreements and internal SOPs.
  • Collect, analyze metric reports related to ICSRs, aggregate reports to ensure the systems and processes are compliant with the study specific plans, SOP and PV regulations
  • Support responses and take corrective actions to PV audits and inspections
  • Lead PV inspection readiness as the Kite Pharma PV operations and subject matter  expert
  • Author, review and approve SOPs as required
  • Escalate critical and major PV gaps to the management to ensure appropriate action
  • Support and participate in PV training of Kite employees
  • Measure and monitor performance of vendors against defined service levels and other metrics.
  • Be able to identify and remediate performance issues to maintain a state of high PV inspection readiness.
  • Supports training of Kite representatives on their safety reporting responsibilities

Requirements:

  • Bachelor’s level degree in life sciences required. Pharmacy, nursing or equivalent required
  • At least 5-8 years of direct Pharmacovigilance operations and/or compliance
  • Experience of Pharmacovigilance standards and training
  • Experience of working with CROs, vendors, and relationship management
  • Strong knowledge of safety database, MedDRA coding and data entry experience.
  • Strong quality focus, with a good understanding of quality systems.
  • Solid knowledge of FDA, EMA, and ICH safety reporting regulations and GVP guidelines.
  • Excellent communicator, both oral and written, specifically medical writing skills

Experience, Skills, Knowledge:

  • Demonstrated experience in communicating across several cross functional groups managing business process outsourcing vendors and relationships.
  • Previous experience in collection and handling metrics related to PV operations
  • 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.

Life sciences Job USA |  Manager position @ Kite Pharma

Kite Pharma, an equal opportunity employer. We are able to offer the upside of working in a small, but growing company where everyone knows your name and respects your opinion while at the same time offering benefits and time off packages commiserate to any large corporation. To learn more about us, please visit our website at www.kitepharma.com

Job Posted date: 7 Sept,2016

How to apply  & View Original Notification: https://careers.jobscore.com/careers/kitepharma/jobs/manager-pharmacovigilance-operations-cTDgQ-voyr5P8GeMg-44q7

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