Chiesi Farmaceutici S.p.A.
Global Pharmacovigilance Operations Manager AIR
Chiesi Farmaceutici S.p.A., Raleigh, North Carolina, United States,
Global 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 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 markets innovative drugs in its main therapeutic areas. We are proud to be the largest global pharmaceutical group to be awarded
B Corp Certification , a recognition of
high social and environmental standards . We are a
reliable
company that adopts and promotes a
transparent and ethical behavior
at all levels. We believe that the success of
Chiesi is built and shaped by our people and our strong set of shared Values and Behaviors . Our people make a critical difference to our success, which is why it is vital that we attract and retain the right talent who will continue to enrich our culture by living and breathing our values and behaviors. In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities. Chiesi Research & Development Our R&D team represents a fundamental asset for the business. It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, global technical development, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, R&D project and portfolio management. Who 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 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 Required
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
Technical Skills
Awareness of EU pharmacovigilance legislation Technical writing capability Up-to-date knowledge of clinical trial requirements Soft Skills
Planning and organizational skills Stress management 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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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 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 markets innovative drugs in its main therapeutic areas. We are proud to be the largest global pharmaceutical group to be awarded
B Corp Certification , a recognition of
high social and environmental standards . We are a
reliable
company that adopts and promotes a
transparent and ethical behavior
at all levels. We believe that the success of
Chiesi is built and shaped by our people and our strong set of shared Values and Behaviors . Our people make a critical difference to our success, which is why it is vital that we attract and retain the right talent who will continue to enrich our culture by living and breathing our values and behaviors. In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities. Chiesi Research & Development Our R&D team represents a fundamental asset for the business. It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, global technical development, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, R&D project and portfolio management. Who 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 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 Required
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
Technical Skills
Awareness of EU pharmacovigilance legislation Technical writing capability Up-to-date knowledge of clinical trial requirements Soft Skills
Planning and organizational skills Stress management 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.
#J-18808-Ljbffr