Lavori attuali relativi a Pharmacovigilance Specialist/Manager Air Expert - Parma, Emilia-Romagna - Chiesi Farmaceutici S.p.A.
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Regulatory Affairs Expert
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QA Specialist
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GPV Operations Specialist/Manager CARE
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Industrial Automation Specialist
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Tendering Manager
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Technical Training Specialist
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Project Manager
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Pharmacovigilance Specialist/Manager Air Expert
1 settimana fa
About Us
Chiesi Farmaceutici S.p.A. is a leading international research-focused pharmaceutical and healthcare group with over 85 years' experience, operating in 31 countries worldwide. Our mission is to improve people's quality of life by acting responsibly towards society and the environment.
We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, recognizing our high social and environmental standards. As a reliable company, we adopt and promote transparent and ethical behavior at all levels.
We believe that our success is built and shaped by our people and our strong set of shared values and behaviors. Therefore, it is vital that we attract and retain the right talent who will continue to enrich our culture by living and breathing our values and behaviors.
Main 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)
- 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 projects
