Lavori attuali relativi a Global Pharmacovigilance Operations Manager - Parma, Emilia-Romagna - Chiesi Group
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Global Pharmacovigilance Operations Manager, Parma
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Parma, Emilia-Romagna, Italia Chiesi Farmaceutici S.P.A. A tempo pienoCompany Overview: Chiesi Farmaceutici S.P.A. is a leading international pharmaceutical and healthcare group with over 85 years of experience, operating in 31 countries with more than 7,000 employees. Our mission is to improve people's quality of life by acting responsibly towards society and the environment.About Us: Based in Parma, Italy, we are committed...
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Logistics Operations Coordinator
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Global Pharmacovigilance Operations Manager
2 mesi fa
We are seeking a skilled Global Pharmacovigilance Operations Manager to support the Global Pharmacovigilance Team in executing and overseeing pharmacovigilance operations activities within the Air Business Unit.
Main ResponsibilitiesKey Functions:
- Collaborate with the 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: 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.
Skills: Awareness of EU pharmacovigilance legislation, technical writing capability, up-to-date knowledge of clinical trial requirements, communication skills, planning and organizational skills, stress management, creative/innovative mindset.
