Gpv Operations Unit Head, Care
3 settimane fa
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 intelligencePlanning and organizational skillsStrategic thinkingProblem solvingStress managementWhat 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
3 settimane fa
Parma, Italia Chiesi Group A tempo pienoWho we are looking for Purpose The “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...
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Gpv Operations Unit Head, Care
3 settimane fa
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
2 settimane fa
Parma, Italia Chiesi Farmaceutici S.P.A. A tempo pienoTeam: 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 employees (Chiesi Group).To achieve its mission of...
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Gpv Operations Unit Head, Care
5 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
3 settimane fa
Parma, Italia Chiesi Farmaceutici S.p.A. A tempo pienoTeam: 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 7,000 employees (Chiesi Group). To achieve its...
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Gpv Operations Unit Head, Care
3 settimane 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 (Chiesi Group). To achieve its mission of...
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Gpv Operations Unit Head, Care
2 settimane fa
Parma, Italia Chiesi Farmaceutici S.P.A. A tempo pienoTeam: 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 7,000 employees (Chiesi Group). To achieve its...
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Gpv Operations Unit Head, Care
3 settimane 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 (Chiesi Group). To achieve its mission of...
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GPV Operations Unit Head, Care
2 settimane 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...
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Gpv Operations Unit Head, Care
1 settimana 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 settimane 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...
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Gpv Operations Unit Head, Care
3 settimane fa
Parma, Italia Chiesi Farmaceutici A tempo pienoDate: 4 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 7,000...
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Parma, Emilia-Romagna, Italia Chiesi A tempo pienoAbout UsChiesi, a leading pharmaceutical and healthcare company, is based in Parma, Italy. With over 85 years of experience and operations in 31 countries, the company has a strong presence globally.We are committed to improving people's quality of life by acting responsibly towards society and the environment. Our mission drives us to research, develop, and...
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Parma, Emilia-Romagna, Italia Chiesi Group A tempo pienoAbout the RoleWe 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...
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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, 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 Group A tempo pienoWho 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...
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Global Pharmacovigilance Operations Manager Air
4 settimane fa
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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Pharmacovigilance Operations Specialist
4 settimane fa
Parma, Emilia-Romagna, Italia Chiesi A tempo pienoAbout ChiesiChiesi 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...
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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...
