Who we are looking for
Purpose
The “Global Pharmacovigilance Operations Manager, Air” supports the Global Pharmacovigilance Team (within R&D) in the execution and oversight of pharmacovigilance operations activities within the “Air” Business Unit.
Main Responsibilities
• Collaborate with Global PV Operations Unit Head, Air in planning GPV Ops activities on specific projects within the AIR business area
• Provide input within the AIR Business Unit
• Manage studies, organized data collections, and Compassionate use/expanded access programs, including non-interventional studies (Post-Authorisation Safety Studies included), reviewing/drafting relevant documents
• Monitor PV operations activities of CROs involved in clinical studies
• Provide assistance to the Integration Manager in the integration phase of company/products acquisition as well as during due diligences
• Manage projects that foresee a collaboration model with other companies in a Global exclusive license agreement, setting up processes and exercising the oversight on their activities
• Participate as a member to regulatory submission teams
• 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
Experience Required
• Minimum 7 years of experience in R&D within Pharmaceutical and/or Biotechnology industry, with at least 3 years of experience in Pharmacovigilance
Education
• Master degree in science, medicine, biology, pharmacy or related fields
Languages
• Fluent English
Technical Skills
• Awareness of EU pharmacovigilance legislation
• Technical writing capability
• Up-to-date knowledge of clinical trial requirements
Soft Skills
* Communication skills
* Planning and organizational skills
* Stress management
* Creative/innovative mindset
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.