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Gpv Operations Specialist/Manager Air
1 mese fa
Team: R&D, Pharmacovigilance & Regulatory Affairs
Job Type: Direct Employee
Contract Type: Permanent
Location: Parma, IT
About us Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years' experience, operating in 31 countries with more than 7,000 employees (Chiesi Group).
To achieve its mission of improving people's quality of life by acting responsibly towards society and the environment, the Group researches, develops and markets innovative drugs in its main therapeutic areas.
We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification , a recognition of high social and environmental standards .
We are a reliable company that adopts and promotes a transparent and ethical behavior at all levels.
We believe that the success of Chiesi is built and shaped by our people and our strong set of shared Values and Behaviors .
Our people make a critical difference to our success, which is why 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.
Chiesi Research & Development Our R&D team represents a fundamental asset for the business.
It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, global technical development, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, R&D project and portfolio management.
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), 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 projects
Experience Required 3 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 Pharmacovigilance will be considered as a plus.
Technical 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 Skills Quality orientation Goal orientation Problem solving Stress management What we offer You 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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