Gpv Psmf & Compliance Sr Specialist

Who we are looking forPurposeTo support GPV in ensuring that Company's pharmacovigilance system is consistent with the regulatory requirements in terms of structure and performancesMain ResponsibilitiesTo evaluate relevant pharmacovigilance regulations, guidelines and recommendations for their applicability to the Company's PV system and support all concerned functions worldwide in the implementation in their areas;To ensure that the PSMF is timely and properly updated by collecting all the requested document from concerned stakeholders, and advices the Head of Global PV & EU-QPPV and other concerned stakeholders on potential changes and amendments;To contribute in the definition of pharmacovigilance KPIs and to propose improvements in their monitoring, evaluation and reporting so to increase the efficiency of the PV system;To track metrics and trends as well as compliance issues and their resolution on a periodic basis;To deliver reports related to the PSMF and KPIs to concerned stakeholders for evaluation of the Global PV system status and performance;To maintain GPV business continuity plan;     Experience RequiredMinimum 5 years of experience in international Pharmacovigilance within Pharmaceutical and/or Biotechnology industry and/or Contract Research OrganisationEducationMaster Degree in life sciences, pharmacy or related fieldsLanguagesEnglish fluent Technical SkillsSoft SkillsCommunication skillsTeam workingDecision makingProblem solvingWhat 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.