Global Pharmacovigilance Operations Manager AIR
2 mesi fa
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.
• 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
• Minimum 7 years of experience in R&D within Pharmaceutical and/or Biotechnology industry, with at least 3 years of experience in Pharmacovigilance
• Master degree in science, medicine, biology, pharmacy or related fields
• Fluent English
Technical 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
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.
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Parma, Italia Chiesi Group A tempo pienoWho we are looking forPurposeThe "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...
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Parma, Italia Chiesi Farmaceutici S.P.A. A tempo pienoGlobal Pharmacovigilance Operations Manager AIR Team: R&D, Pharmacovigilance & Regulatory Affairs Job Type: Direct Employee Contract Type: Permanent Location: Parma, IT About us Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years' experience, operating in 31 countries with more than...
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Parma, Italia Chiesi Farmaceutici S.P.A. A tempo pienoGlobal Pharmacovigilance Operations Manager AIRTeam: RD, Pharmacovigilance Regulatory AffairsJob Type: Direct EmployeeContract Type: PermanentLocation: Parma, ITAbout usBased in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years' experience, operating in 31 countries with more than 7,000...
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Parma, Italia Chiesi Farmaceutici S.P.A. A tempo pienoGlobal Pharmacovigilance Operations Manager AIRTeam: R&D, Pharmacovigilance & Regulatory AffairsJob Type: Direct EmployeeContract Type: PermanentLocation: Parma, ITAbout us Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years' experience, operating in 31 countries with more than 7,000...
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Parma, Italia Chiesi A tempo pienoAbout usBased in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience, operating in 31 countries with more than 7,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group...
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Parma, Emilia-Romagna, Italia Chiesi Group A tempo pienoJob DescriptionWe are seeking a highly skilled Global Pharmacovigilance Operations Manager to join our team. As a key member of our R&D department, you will play a crucial role in ensuring the successful execution and oversight of pharmacovigilance operations activities within our Air Business Unit.Main ResponsibilitiesCollaborate with the Global PV...
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Parma, Emilia-Romagna, Italia Chiesi A tempo pienoAbout UsChiesi, an international pharmaceutical and healthcare group based in Parma, Italy, is renowned for its research-driven approach. With over 85 years of experience and operations in 31 countries, the company employs more than 7,000 individuals worldwide.The RoleWe are seeking a skilled Global Pharmacovigilance Operations Manager to support the Global...
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Parma, Italia Chiesi Farmaceutici S.P.A. A tempo pienoSelect how often (in days) to receive an alert: Global Pharmacovigilance Digital Innovation & Technologies Manager Team: R&D, Pharmacovigilance & Regulatory Affairs Job Type: Direct Employee Contract Type: Permanent Location: Parma, IT About us Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85...
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Parma, Italia Chiesi Farmaceutici A tempo pienoDate: 11 Nov 2024 Department: Global Pharmacovigilance Team: R&D, Pharmacovigilance & Regulatory Affairs Job Type: Direct Employee Contract Type: Permanent Location: Parma, IT About us Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years' experience, operating in 31 countries with...
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Parma, Italia Chiesi Farmaceutici A tempo pienoDate: 11 Nov 2024 Department: Global Pharmacovigilance Team: R&D, Pharmacovigilance & Regulatory Affairs Job Type: Direct Employee Contract Type: Permanent Location: Parma, IT About us Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years' experience, operating in 31 countries with more than...
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Parma, Italia Chiesi Farmaceutici A tempo pienoDate: 11 Nov 2024Department: Global PharmacovigilanceTeam: R&D, Pharmacovigilance & Regulatory AffairsJob Type: Direct EmployeeContract Type: PermanentLocation: Parma, ITAbout usBased in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience, operating in 31 countries with more than...
