GPV Operations Unit Head, Care

3 giorni fa

Parma, Italia Chiesi A tempo pieno
About 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, develops and markets innovative drugs in its main therapeutic areas: Discover more hereWe 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 & DevelopmentOur 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.

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 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.

  • Gpv Operations Unit Head, Care

    2 settimane fa

    Parma, Italia Chiesi Group A tempo pieno

    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...

  • GPV Operations Unit Head, Care

    2 settimane fa

    Parma, Italia Chiesi Group A tempo pieno

    Who 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...

  • Gpv Operations Unit Head, Care

    2 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...

  • Gpv Operations Unit Head, Care

    1 settimana fa

    Parma, Italia Chiesi Farmaceutici S.P.A. A tempo pieno

    Team: 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...

  • GPV Operations Unit Head, Care

    2 settimane fa

    Parma, Italia Chiesi Farmaceutici S.p.A. A tempo pieno

    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 (Chiesi Group). To achieve its...

  • Gpv Operations Unit Head, Care

    2 settimane fa

    Parma, Italia Chiesi Farmaceutici S.P.A. A tempo pieno

    Team: 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...

  • Gpv Operations Unit Head, Care

    1 settimana fa

    Parma, Italia Chiesi Farmaceutici S.P.A. A tempo pieno

    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 (Chiesi Group). To achieve its...

  • Gpv Operations Unit Head, Care

    2 settimane fa

    Parma, Italia Chiesi Farmaceutici S.P.A. A tempo pieno

    Team: 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...

  • Gpv Operations Unit Head, Care

    7 ore fa

    Parma, Italia Chiesi A tempo pieno

    About 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,...

  • GPV Operations Unit Head, Care

    3 giorni fa

    Parma, Italia Chiesi A tempo pieno

    About 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...

  • Gpv Operations Unit Head, Care

    2 settimane fa

    Parma, Italia Chiesi Farmaceutici A tempo pieno

    Date: 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...

  • Global Pharmacovigilance Operations Manager

    4 settimane fa

    Parma, Emilia-Romagna, Italia Chiesi Group A tempo pieno

    About 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...

  • Global Pharmacovigilance Operations Manager: Spearheading Regulatory Compliance

    5 giorni fa

    Parma, Emilia-Romagna, Italia Chiesi Group A tempo pieno

    Job 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...

  • Global Pharmacovigilance Operations Manager Air

    4 settimane fa

    Parma, Italia Chiesi Group A tempo pieno

    Who 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...

  • Global Pharmacovigilance Operations Manager AIR

    4 settimane fa

    Parma, Italia Chiesi Group A tempo pieno

    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...

  • Global Pharmacovigilance Operations Manager Air

    3 settimane fa

    Parma, Italia Chiesi Farmaceutici S.P.A. A tempo pieno

    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...

  • Pharmacovigilance Operations Specialist

    3 settimane fa

    Parma, Emilia-Romagna, Italia Chiesi A tempo pieno

    About 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...

  • Global Pharmacovigilance Operations Manager Air

    3 settimane fa

    Parma, Italia Chiesi Farmaceutici S.P.A. A tempo pieno

    Global 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...

  • Global Pharmacovigilance Operations Manager AIR

    3 settimane fa

    Parma, Italia Chiesi Farmaceutici S.p.A. A tempo pieno

    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...

  • Global Pharmacovigilance Operations Manager AIR

    4 settimane fa

    Parma, Italia Chiesi Farmaceutici S.p.A. A tempo pieno

    Global Pharmacovigilance Operations Manager AIRTeam: 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...