About Chiesi
We are an international research-focused pharmaceutical and healthcare group with over 85 years of experience, operating in 31 countries with more than 7,000 employees. We have a strong commitment to improving people's quality of life by acting responsibly towards society and the environment.
Our Mission
To achieve our mission, we research, develop and market innovative drugs in our main therapeutic areas: respiratory, rare diseases, neuroscience, and immunology. Our goal is to make a positive impact on people's lives while promoting sustainability and social responsibility.
Who We Are Looking For
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.
Requirements:
* 3 years of experience in Pharmacovigilance within Pharmaceutical and/or Biotechnology industry, with at least 1 year of experience in Post-Market safety.
* Master degree in science, medicine, biology, pharmacy or related fields.
You would join a dynamic, fast-growing, challenging and friendly environment. At 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.