Associate Director Pharmacovigilance IT Solutions

  • Veröffentlicht am 05.09.2021
  • Festanstellung
  • Friedrichsdorf

Einleitung

Your Job The actual tasks to be performed depend on the PV projects assigned and the candidate’s experience and expertise. They most likely include:
  • Collaboration in designing the strategy for the coordinated service Digital Solutions in Pharmacovigilance with the Heads of department
  • Communication and implementation of decisions of the Heads in the coordinated service area
  • Representation of the service and tools to stakeholders, including support during PV audits and inspections
  • Take over responsibility for planning, managing and feasibility of projects within the coordinated service area
  • Setup, maintenance and development of technology enabled system services / PharmaLex’ technology solutions within the Pharmacovigilance department
  • Economic steering and monitoring of all projects within the coordinated service area, including safety database and data migration projects
  •  Ensure and maintain computer system validation status of relevant systems
  • Coordination of an international team to ensure internal support for relevant computerized systems
  • Optimization of processes regarding the coordinated service, including process ownership and currentness of related SOPs
  • Your Profile

  • Master’s Degree in life sciences
  • At least three years of experience in pharmacovigilance and related aspects
  • Ideally the candidate should have worked for a PV service provider on different client projects or in a corporate PV department with exposure to relevant PV/project management tasks
  • Experience in managing computerized systems (e.g. maintenance of PV safety databases), including vendor management
  • Experience in computer system validation processes, and data migration projects
  • Experience in participating audits and inspections
  • Coordination of and working with international teams, ideally in virtual environments
  • Knowledge of the applicable legislation (e.g. GVP)
  • Knowledge of computer system validation procedures and legislation (e.g. 21 CFR Part 11, EudraLex Volume 4 Annex 11, GAMP5)
  • Knowledge of Pharmacovigilance Safety Databases
  • Ideally, knowledge of PV system structures and principles
  • Project management experience
  • Very good command of English language
  • Very good knowledge of MS Office applications
  • Ideally, an understanding of software development processes, programming and databases
  • Team player
  • Ability to adjust rapidly to new, unknown, challenging situations
  • High affinity to technology, and a strong determination to learn new applications
  • Structured, solution-oriented and independent working style
  • Initiative and decision-making ability
  • Willingness to take responsibility

  • Standort

    PharmaLex, Friedrichsdorf
    https://www.absolventa.de/stellenangebote/4916197-b-associate-director-pharmacovigilance-it-solutions
    Jobs per E-Mail
    Deine Suchkriterien.
    Gesundheit
    Pharma
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