Pv information system project lead

Nous sommes un groupe pharmaceutique à dimension humaine, international et indépendant, gouverné par une Fondation. Notre modèle, singulier, fait notre fierté mais, surtout, nous permet de servir pleinement notre vocation : « engagés pour le progrès thérapeutique au bénéfice des patients ». Aujourd’hui leader mondial en cardiologie, nous avons choisi de devenir un acteur focalisé et innovant en oncologie d’ici 2030, en ciblant des cancers difficiles à traiter et en y consacrant plus de 70 % de notre budget R&D. Un défi que nous poursuivons en parallèle du développement de notre activité générique pour un accès à des soins de qualité pour tous, et à moindre coût.

Nous ? 21 900 passionnés de plus de 50 nationalités, portés par un esprit d’entreprenariat. Chaque jour nous avançons avec et pour les patients, avec et pour nos équipes, portés par l’envie de prendre soin, d’oser, de nous développer, de nous engager pour être utiles à celles et ceux qui en ont besoin.

Venez vivre et contribuez à faire vivre notre engagement #MovedByYou
https://servier.com/groupe/


Activities & Responsabilities

As for PV Tools management, S/He is responsible for:

* Setting up and maintaining the Global Safety database to support PV activities handled by Global Safety and ensure regulatory compliance..
* Ensuring proper configuration and maintenance of PV systems in alignment with business and regulatory requirements in close collaboration with Information Systems Department (ISD) including but not limited to product management, clinical study management, interface management, management of E2B messages/profiles.
* Configuring and maintaining the processes for expedited reporting (immediate transmission) of pharmacovigilance cases to relevant countries in accordance with local regulatory requirements and business partner agreements (via electronic transmission or through local pharmacovigilance representatives).
* Conducting impact analysis to proactively prevent and ensuring that incidents are addressed by the appropriate teams.
* Delivering user training in accordance with the company’s access management policy.
* Contributing to the system validation activities in accordance with the validation strategy and plans established by the dedicated Quality Assurance (QA) department.
* Assisting with the definition and gathering requirements for Key performance indicators (KPIs) for assigned global safety systems and tools
* Monitoring of the individual case safety report (ICSR) transmissions within the Global safety database.
* Contributing to the development, enhancement, and maintenance of assigned IT tools to support business needs of Global Safety

As for Project management, S/He is responsible for:

* Contributing GS system upgrade projects in alignment with the strategy defined by the Global Safety in collaboration with ISD department, solution vendors, and potential integrators.
* Participating in all project phases for GS Systems including the definition of business and regulatory requirements, vendor and integrator selection.
* Contributing to impact analysis and change management activities related to GS Systems projects to ensure smooth implementation and minimal disruption. *

Profile & Experience

* Scientific degree or degree in Information Technology/Computer Science
* At least 10 years of experience within the pharmaceutical industry, specifically in the pharmacovigilance field, within an international environment particularly in activitiesrelated to pharmacovigilance cases management and expedited reporting
* Proven experience managing system and process changes in regulated environments (especially pharmacovigilance), including Impact assessment
* Demonstrated experience in preparation for and participation in audits and regulatory inspections
* Excellent knowledge of global pharmacovigilance regulatory requirements
* Solid understanding of quality management obligations in GxP environments (including Deviation management, CAPA etc.,)
* Knowledge and interest in IT tools supporting pharmacovigilance activities
* Experience managing validation of IT system configurations dedicated to pharmacovigilance activities.
* Managing Business intelligence tools including the creation of queries and line listings
* Fluency in English.

IT aptitude

Strong IT experience: pack office, databases, and reporting tools.

Leadership skills and aptitudes

* Strong problem-solving abilities and solution-oriented mindset.
* Ability to identify and implement effective solutions within area of responsibility.
* Sound decision-making skills, with the ability to take appropriate actions in line with regulatory obligations and escalate to management when needed.
* Ability to prioritize tasks and lead multiple topics, projects, and workgroups.
* Proven ability to meet deadlines and deliver high-quality outputs.
* Demonstrated adaptability and resilience in managing change within a dynamic and evolving environment.
* Ability to communicate openly and encourage open dialogue within the team and across functions.
* Proactive in proposing improvements that support the objectives of Global Safety, in collaboration with line management.
* Ability to anticipate and identify potential issues and develop compliant, effective solutions.
* Creative thinking and willingness to propose innovative solutions ("thinking outside the box").
* Strong aptitude for learning new skills and technologies related to pharmacovigilance systems.
* Proven ability to adapt to change and manage cultural change in an evolving environment
* Ability to speak forthrightly and encourage others to do the same
* Ability to propose and make proposals that benefit the Global Safety in collaboration with the line management
* Ability to foresee and identify issues and then propose and develop solutions in compliance with the legal requirements

Nous sommes engagés pour l’égalité des chances et le développement des talents dans toute leur diversité. Nous accordons autant de valeur à l’expérience qu’à l’envie de s’engager au quotidien pour être utile au progrès thérapeutique au bénéfice des patients. Si vous vous reconnaissez dans cette offre et ces quelques lignes, saisissez cette opportunité de nous rencontrer.