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Process Excellence Specialist

Process Excellence Specialist

United BioSourceSpain, ES
Hace más de 30 días
Descripción del trabajo

As a pharmaceutical support industry leader , UBC is devoted to empowering health solutions for a better tomorrow . We take pride in improving  patient outcomes and advancing healthcare.  At UBC, we provide services to enhance the entire drug development process and commercialization lifecycle - From clinical trial support to real-world evidence generation.

Embark on a rewarding career journey with UBC as a Process Excellence Specialist! Grow your career while making a meaningful impact  on the world around you. UBC fosters a culture built on our Core Values of Collaboration, Conscientiousness, Curiosity, Compassion and Consultation. We believe in an inclusive workplace that fosters creativity.

If you are seeking a career that will challenge, inspire, and reward you, join us at UBC!

As a Process Excellence Specialist, you will manage Pharmacovigilance System Master Files for clients and provide support for quality management system aspects.

Specific job duties :

  • Management of deviations and CAPAs.
  • Production of standardized quality metrics for the UBC Global PV Department and for PV projects contracted by UBC clients.
  • Support PV Management in the development and maintenance of the UBC PV procedural documents and for serving as the lead global PV trainer.
  • Is involved in the prioritization and dissemination of information relating to global PV Safety Regulatory Intelligence.
  • Responsible for the management of Pharmacovigilance System Master files writing and update for European clients, support for quality management system related aspects :

Supervisory Responsibility :

N / A

Skills and Qualifications :

  • Previous experience managing the Pharmacovigilance System Master Files, writing and updating.
  • Experience in providing support for quality management system related aspects
  • Previous experience in managing deviations and CAPAs,
  • Experience in producing standardized quality metrics for the UBC Global PV Department and for PV projects contracted by UBC clients.
  • Previous experience in supporting PV Management in the development and maintenance of the UBC PV procedural documents.
  • Ability to prioritize and disseminate information relating to global PV Safety Regulatory Intelligence.
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