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Director, Good Pharmacovigilance Practice Quality

Quality | Santa Monica, CA | Full Time

Job Description

About Us:

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.

We are seeking a highly motivated individual to join us as a Director, Good Pharmacovigilance Practice (GVP) Quality.  You will work within the GCP Quality team in supporting our efforts in this exciting new area of cancer immunotherapy. This role will be a hands-on resource reporting to the Executive Director, GCP Quality.

Responsibilities:

  • Manages and assists in implementing and maintaining a comprehensive risk-based GVP/GCP compliant quality program

  • Assists in setting annual audit schedule and budget.

  • Manages and conducts GVP specific external site and vendor audits for compliance per regulations, PV agreements and internal SOP's.

  • Collects and analyzes metric reports related to ICSRs, aggregate reports to ensure the systems and processes are compliant with the study specific plans, SOPs and PV regulations.

  • Supports global regulatory agency inspections and other audits.

  • Provides input to GVP related Corrective and Preventive Action plans.

  • Authors, reviews and approves GVP related procedural documents as required.

  • Responsible for GVP regulatory intelligence

  • Escalates critical and major PV gaps to the mangement to ensure appropriate action.

  • Maintains and participates in PV training of employees on their safety reporting responsibilties.

  • Identify and remediate performance issues to maintain a state of high PV inspection readiness.

Requirements:

  • Bachelor's level degree in life sciences required. Pharmacy, nursing or equivalent required, advanced degree preferred.

  • At least 5-8 years of direct Pharmacovigilance compliance, standards and training experience is required.

  • Solid knowledge of GCP/GVP regulations and guidelines (including FDA, EMA and ICH safety reporting).

  • Experience of Pharmacovigilance operations is strongly preferred.

  • Experience working with CROs, vendors and relationship management preferred.

  • Familiar with Company Pharmacovigilance Summary Master File (PSMF) document and have the ability to contribute towards required audit-related information.

  • Strong knowledge of electronic systems used to manage clinical trial data and safety reporting (i.e. eTMF, EDC, Argus, ArisG, IVRS).

  • Strong quality focus with a good understanding of quality systems.

  • 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 compliance.

  • Strong relationship building skills, with ability to interact effectively in a multi-functional and multi-cultural team setting.

  • Excellent written and verbal communication skills to a variety of levels/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 Pharma, is headquartered in Santa Monica, CA. To learn more about us, please visit our website at www.kitepharma.com

If you are interested in applying for this opportunity, please submit your resume or CV, cover letter and salary requirements.  All submissions will be evaluated and interviews will be conducted for those applicants who most strongly fit our needs. If you are not contacted for an interview, your resume will remain on file and active for available positions for a period of one year.

 

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