Who we are looking forPurposeThe “eTMF PV Specialist” supports the Global PS Team (within R&D) in the execution and oversight of eTMF activities with regards to Chiesi sponsored GCD and GRD studies.Main ResponsibilitiesPlan all Trial Master File (TMF) activities related to Patient Safety, to guide and oversee providers and to ensure quality and TMF audit / inspection readinessEnsure that all the PS documents are archived in accordance with SOPs and study specific characteristicsPlan TMF activities for the assigned studies and write / review the TMF planUpload documents in the eTMF for documents created internallyPerform Quality review of documents filed in TMFParticipate / support audit and inspections to TMFContribute to eTMF process improvement, development of standards and internal system developmentTrain the team and external stakeholders on rules and requirementsEnsure PS documents related to clinical trials are properly stored in the PS common repositoryReview / Contribute to SOPs / Wis related to eTMF managementAct as Subject Matter Expert of Chiesi eTMF solutionMaintain compliance with relevant regulations, policies and proceduresParticipate in the internal departmental meetings and project-specific teamsRepresent GPV department in cross-functional corporate teams and projectTake care about regulatory compliance with regards to clinical trials submissionsOpen and manage GCP deviations in case of issues and manage relative CAPAsExperience RequiredMinimum 8 years of experience in R&D within Pharmaceutical and / or Biotechnology industry / company, with at least 4 years of experience in Pharmacovigilance eTMF managementEducationMaster’s degree in science, medicine, biology, pharmacy or related fields, PhD or similar preferredLanguagesGood knowledge of English (both written and spoken)Technical SkillsAwareness of EU pharmacovigilance legislation and the principles of global pharmacovigilance requirements including knowledge of PV quality systems and regulatory requirements across US and other countries and regionsUp-to-date knowledge of local / global CT regulations and respective need for compliance (e.g. Good Clinical Practice)Strong technical and problem-solving skills / experience.Excellent communication and interpersonal skillsAbility to work with cross-functional teams, with a clear result-oriented approachDemonstrates good initiative, creativity and innovation skills.Ability to organize and prioritize tasks both individually and across a team to achieve established deadlinesSoft SkillsAnalytical skillsCommunication skillsPlanning and organizational skillsTeam workingWhat we offerYou would join a dynamic, fast-growing, challenging and friendly environment.In Chiesi we firmly believe that our people are our most valuable asset , that is why we invest in continuous training, learning and development. Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective well-being.We want our people to come to work happy every day , and we know how important it is to find the right work-life balance in order to be able to give our best. That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people-care services.
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