GPV Operations Unit Head, Care
2 giorni fa
Headquartered in the new purpose-built and fully integrated Research and Development Centre in Parma (Italy), the team also has important operations in Paris (France), Chippenham (UK), Cary (US), Stockholm (Sweden), Toronto (Canada) and Shanghai (China).Who we are looking forPurposeThe “Global Pharmacovigilance Operations Unit Head, Care” supports the Global Pharmacovigilance Team (within R&D) in the execution and oversight of premarket and postmarket pharmacovigilance operations activities within the “Care” Business Unit.Main Responsibilities•
Collaborate with Global PV Operations Department Head in planning GPV Ops activities, maintaining him/her updated on projects status and escalating in case of issues •
Provide input within the Care Business Unit •
Supervise the activities of Specialists in the Care Business Unit within GPV Ops and follow their performance and development plan •
Oversight studies, organized data collections, and Compassionate use/expanded access programs, including non-interventional studies (Post-Authorisation Safety Studies [PASSs] included), revising/drafting relevant documents •
Monitor PV operations performance of CROs involved in clinical studies and escalate in case of issues •
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 and response 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 •
Maintain compliance to relevant regulations, policies and procedures •
Participate to the internal departmental meetings and project-specific teams •
Represent GPV department in cross-functional corporate teams and projects Experience Required•
Minimum 10 years of experience in R&D within Pharmaceutical and/or Biotechnology industry, with at least 6 years of experience in Pharmacovigilance Education•
Master degree in science, medicine, biology, pharmacy or related fields, PhD or similar preferred LanguagesEnglish fluentTechnical Skills•
Awareness of EU pharmacovigilance legislation and the principles of global pharmacovigilance requirements including knowledge of PV quality systems and regulatory requirements across US and other countries and regions •
Knowledge of EMA GvP modules •
Technical writing capability •
Up-to-date knowledge of local/ global CT regulations and respective need for compliance (e.g. Good Clinical Practice) •
Knowledge of MedDRA coding dictionary and its principles Soft SkillsEmotional and social intelligence Planning and organizational skills Strategic thinking Problem solving Stress management What we offerYou 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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Gpv Operations Unit Head, Care
5 giorni fa
Parma, Italia Hitachi Vantara Corporation A tempo pienoAbout 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 employees. To achieve its mission of improving people's quality of life by acting responsibly towards society and the environment, the Group researches, develops and...
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Gpv Operations Unit Head, Care
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GPV Operations Unit Head, Care
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Gpv Operations Unit Head, Care
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GPV Operations Unit Head, Care
3 giorni fa
Parma, Italia Hitachi Vantara Corporation 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. To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group researches, develops and...
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Gpv Operations Unit Head, Care
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Parma, Italia Hitachi Vantara Corporation 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.To achieve its mission of improving people's quality of life by acting responsibly towards society and the environment, the Group researches, develops and...
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Gpv Operations Unit Head, Care
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Gpv Operations Unit Head, Care
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Gpv Operations Unit Head, Care
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Parma, Italia Chiesi Farmaceutici A tempo pieno**Date**:4 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...
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Gpv Operations Unit Head, Care
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Gpv Operations Unit Head, Care
2 giorni fa
Parma, Italia Chiesi Farmaceutici S.P.A. A tempo pienoTeam: 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 employees.To achieve its mission of improving...
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Gpv Operations Unit Head, Care
2 giorni fa
Parma, Italia Chiesi Farmaceutici A tempo pienoDate: 4 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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Gpv Operations Unit Head, Care
2 giorni fa
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 researches,...
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Gpv Operations Unit Head, Care
2 giorni fa
Parma, Italia Chiesi Farmaceutici S.P.A. A tempo pienoTeam: 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 7,000 employees.To achieve its mission of improving...
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Parma, Emilia-Romagna, Italia Chiesi A tempo pienoAbout Us\rChiesi is a leading pharmaceutical and healthcare company with a rich history spanning over 85 years. With operations in 31 countries and a global team of over 7,000 employees, we strive to improve people’s quality of life by acting responsibly towards society and the environment.\rWe are proud to be the largest global pharmaceutical group to be...
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Parma, Emilia-Romagna, Italia Chiesi Farmaceutici A tempo pienoCompany OverviewChiesi Farmaceutici is a leading pharmaceutical company with over 85 years of experience in research and development. Headquartered in Parma, Italy, the company operates globally with over 7,000 employees across 31 countries.The company's mission is to improve people's quality of life by acting responsibly towards society and the environment....
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Parma, Italia Chiesi Group A tempo pienoWho we are looking forPurpose• To design, drive, and oversee cross-functional projects within GPV and between functions aiming at increasing the value that GPV can bring to the Chiesi business.• To oversee signal and risk management activities for Chiesi products to ensure patient safety and compliance with global regulatory and quality...
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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 researches,...
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Head Of Global Pharmacovigilance Center Of
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Parma, Italia Chiesi Farmaceutici A tempo pieno**Date**:18 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...
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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...
