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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: Discover more here 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.
In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.
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. Headquartered in the new purpose-built and fully integrated Research and Development Centre in Parma (Italy), the team also has important operations in Paris (France), Chippenham (UK), Cary (US), Stockholm (Sweden), Toronto (Canada) and Shanghai (China).
Who we are looking for PurposeTo support and facilitate the clinical risk assessment and management activities in GCD clinical studies in compliance with regulations and guidelines (including escalation and specific reporting).
Main ResponsibilitiesCollaborates with GCD (Global Clinical Development Dept) clinical study teams for:
Quality-by-design principles in GCD protocolsIdentification of critical to quality factors (CtQ) of GCD protocols leading to setup of Quality Tolerance Limits (QTLs) in clinical studiesTaylor mitigation actions for risks identifiedCtQ protocol analysis, to propose QTL parameters to study teams and to chair team discussions, QTL specification plans or study specific risk assessments and set up of risk management within studies (Study risk registers, set up of Key Risk indicators, Central monitoring strategy)Provides clinical risk assessment input during study design meetings and other internal governance meetings when required.Integrated Quality Risk Management Plan and related Study functional plans review and input from risk-based approachInteractions with risk-based system experts from CRO for setup and go-liveReporting
• Reports overall risks review analyses on GCD programs and/or studies.
• Risk Review activities (monthly per study at least)
• Responsible to control the status of any mitigation plans specifically requested by Chiesi Risk Evaluation Committee in response to issues raised by clinical risk management.
• Escalates to risk owner(s) any issues impacting the project and requiring GCD decisions as per escalation or communication plans/procedures
Trials closure phase:
• Reviews the appropriate risk sections of the Clinical Study Report (CSR) and provide the final risk assessment report as appendices if appropriate
• Ensures Risks review lesson learnt dissemination within GCD collaborators
Experience Required3-5 years of experience in Clinical Research oversight and risk assessment operations in a pharmaceutical company
EducationHigh level scientific degree (i.e. pharmacy, biology)
LanguagesTechnical SkillsKnowledge of ICH/GCP, regulatory frameKnowledge of principles of Clinical ResearchKnowledge of therapeutic areasKnowledge of risk assessment and analytics toolsSoft SkillsAnalytical skillsPlanning and organizational skillsProblem solvingWhat 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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