Gpv Operations Specialist/Manager Air Parma

Gpv Operations Specialist/Manager Air
Parma
Emilia Romagna, Parma

Who we are looking forMain Responsibilities•     Collaborate with Global PV Operations Unit Head, Specialists and Managers in specific projects within the assigned Business Area•     Provide input within the GPV specific Business Unit•     Manage clinical trials, organized data collections, and Compassionate use/expanded access programs, including non-interventional studies (Post-Authorisation Safety Studies [PASSs] included), revising/drafting/archiving relevant documents•     Oversight/review adverse event reports for investigational medicinal products or marketed drugs, ensuring compliance with regulatory guidelines and completeness of documentation•     Monitor PV operations activities of CROs involved in studies•     Perform Quality Control activities•     Provide inputs on global SOPs and WIs and other controlled documents•     Support other PV activities, both at global and affiliate level•     Be responsible for cross-functional projects and processes•     Participate in audit and inspection activities•     Maintain compliance to relevant regulations, policies and procedures•     Participate to the Departmental meetings and project-specific teams•     Represent GPV department in cross-functional corporate teams and projectsExperience Required3 years of experience in Pharmacovigilance within Pharmaceutical and/or Biotechnology industry, with at least 1 years of experience in Post-Market safety Education•     Master degree in science, medicine, biology, pharmacy or related fields;•     Additional background in Pharmacovigliance will be considered as a plus LanguagesFluent englishTechnical Skills•     Knowledge of national and international regulatory safety reporting requirements (post-marketing and clinical trials)•     Knowledge of MedDRA coding dictionary and its principles •     Ability in managing performance and projects•     IT Skills: Office package; safety database and other data management systems Soft SkillsAttention to detailsQuality orientationTeam workingGoal orientationProblem solvingStress managementWhat 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.