Social network you want to login/join with:GPV Operations Specialist/Manager Air, ParmaClient: Chiesi GroupLocation: Parma, ItalyJob Category: OtherEU work permit required: YesJob Reference: a57a6b4a7932Job Views: 2Posted: 24.04.2025Expiry Date: 08.06.2025Job DescriptionWho we are looking forMain ResponsibilitiesCollaborate with the Global PV Operations Unit Head, Specialists, and Managers on projects within the assigned Business Area.Provide input within the GPV specific Business Unit.Manage clinical trials, data collection, and Compassionate use/expanded access programs, including non-interventional studies like PASSs, and revise/draft/archive relevant documents.Oversee/review adverse event reports for investigational and marketed drugs, ensuring regulatory compliance and documentation completeness.Monitor PV activities of CROs involved in studies.Perform Quality Control activities.Contribute to global SOPs, WIs, and other controlled documents.Support other PV activities globally and at the affiliate level.Lead cross-functional projects and processes.Participate in audits and inspections.Ensure compliance with regulations, policies, and procedures.Participate in departmental meetings and project teams.Represent the GPV department in cross-functional teams and projects.Experience RequiredAt least 3 years of Pharmacovigilance experience in the Pharmaceutical or Biotechnology industry, including a minimum of 1 year in Post-Market safety.EducationMaster's degree in science, medicine, biology, pharmacy, or related fields. Additional Pharmacovigilance background is a plus.LanguagesTechnical SkillsKnowledge of national and international safety reporting regulations (post-marketing and clinical trials).Knowledge of MedDRA coding principles.Project and performance management skills.Proficiency in Office suite, safety databases, and data management systems.Soft SkillsQuality orientationGoal orientationProblem solvingStress managementWhat we offerJoin a dynamic, fast-growing, challenging, and friendly environment. At Chiesi, we believe our people are our most valuable asset, investing in continuous training, learning, and development. We promote a healthy work environment and collective well-being, offering flexible working arrangements, remote work, relocation support, tax assistance for foreign colleagues, and other people-care services.
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