Pharmacovigilance Operations Specialist
2 settimane fa
About Chiesi
Chiesi is a leading international pharmaceutical group with a strong research focus. With over 85 years of experience, we operate in 31 countries and have a global team of over 7,000 employees.
We are committed to improving people's quality of life by acting responsibly towards society and the environment. Our innovative approach to drug development and our commitment to excellence have earned us a reputation as a reliable partner in the healthcare industry.
Job Overview
We are seeking a skilled Global Pharmacovigilance Operations Manager to join our team. The successful candidate will support the Global Pharmacovigilance Team in the execution and oversight of pharmacovigilance operations activities within the Air Business Unit.
Key Responsibilities
- Collaborate with the Global PV Operations Unit Head to plan and execute GPV Ops activities within the Air business area.
- Provide input and support to the AIR Business Unit on pharmacovigilance operations.
- Manage studies, organized data collections, and Compassionate use/expanded access programs, including non-interventional studies (Post-Authorisation Safety Studies included).
- Monitor PV operations activities of CROs involved in clinical studies.
- Support the Integration Manager in the integration phase of company/product acquisitions.
- Manage projects involving collaboration models with other companies in a Global exclusive license agreement.
- Participate in regulatory submission teams and provide inputs on global SOPs and WIs.
- Support other PV activities at global and affiliate levels.
- Be responsible for cross-functional projects and processes.
- Participate in audit and inspection activities.
Requirements
We are looking for a candidate with a minimum of 7 years of experience in R&D within the pharmaceutical and/or biotechnology industry, with at least 3 years of experience in pharmacovigilance. A master's degree in science, medicine, biology, pharmacy, or a related field is required. Fluency in English is essential, and awareness of EU pharmacovigilance legislation is a must.
Why Join Chiesi?
We offer a dynamic, fast-growing, and challenging environment where you can develop your skills and expertise. We believe in investing in our people and providing continuous training and learning opportunities. We also offer flexible working arrangements, remote working options, and support for relocation and well-being.
About the Company
Chiesi is a global pharmaceutical company with a strong research focus. We are committed to improving people's quality of life by acting responsibly towards society and the environment. Our innovative approach to drug development and our commitment to excellence have earned us a reputation as a reliable partner in the healthcare industry.
Our Values
We believe that our people are our most valuable asset. We strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and collective well-being. We want our people to come to work happy every day and find the right work-life balance to give their best.
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