GRAPS Safety Operations, Clinical Trials Manager

16 set - Italia
Chiesi Group

Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. As a Agevolazioni Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact.
We believe our differences make us stronger. 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).

To carry out pharmacovigilance (PV) operations (OPS) activities in interventional clinical trials (CT) sponsored either by GCD or GRD functions by maintaining up-to-date processes for safety-related aspects of interventional clinical trials, to meet current and evolving PV legislation

Support the GRAPS Safety Operations CT Head in ensuring that all current PV requirements for interventional clinical trials are effectively incorporated into Chiesi processes and documented in procedures
Ensure strategic collection, assessment and delivery of high-quality clinical trial safety data in a timely manner, ensuring that it is correct, consistent, compliant and delivered to agencies
Actively engage CT customers, affiliates and other stakeholders
Participate in interdepartmental mee

Meccanico - 0149

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