Global Pharmacovigilance Digital Innovation

2 ore fa

Parma, Italia Chiesi Farmaceutici A tempo pieno

Date: 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 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 here.

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. 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 for

Purpose
Lead, promote, and accelerate the innovation of PV technologies. Serve as the primary point of contact for the Pharmacovigilance community regarding the introduction, validation, training, and maintenance of tools for PV document management (e.g., electronic safety document management systems, front-end solutions, robotic process automation). Support the daily maintenance activities related to digital tools used by Global Pharmacovigilance to keep them updated, thereby making a real impact on patient safety.

Main Responsibilities
  • Contribute to designing tailor-made Pharmacovigilance IT solutions for the assigned area, ensuring they are kept up-to-date to achieve the company’s objectives and goals.
  • Act as a facilitator during project management design for the implementation of new solutions in the assigned area or the upgrade of existing ones.
  • Be responsible for Pharmacovigilance processes related to the assigned tools, including writing SOPs, WIs, and Internal Guidelines.
  • Plan and supervise the implementation of IT solutions in the assigned Pharmacovigilance area.
  • Serve as the point of contact for IT Service Providers and the Global Information and Communications Technology (GICT) department for the assigned systems.
  • Assist PV Users (as the first point of contact) and PV Service Providers in the daily use of the assigned tools, evaluate their skills, and organize necessary training activities.
  • Act as the key user for the assigned tools, keep the assigned sections (e.g., setting sections) updated and ensure that documents are stored following the procedures.
  • Oversee local requirements that impact the assigned systems.
  • Open deviations related to the activities under the role and contribute to investigations and the implementation of CAPA plans.
  • Support change control management when Global Pharmacovigilance (GPV) assigned tools are impacted.
  • Participate in activities related to acquisition and integration, including data migration for the assigned tools.
  • Participate in audit and inspection activities.
  • Provide data for the budget related to the assigned tools.
  • Be responsible for providing information to be included in the Pharmacovigilance System Master File (PSMF) for the assigned tools.
  • Be responsible for the qualification of spreadsheets used in GPV.
  • Contribute to assessing PV technology requirements (i.e., innovation), prioritizing new needs, and developing evolutionary strategies for Pharmacovigilance in collaboration with GPV, GICT, and key digital functional areas of the company.
  • Support and act as a backup for the Business Administrator for the Global Safety Database (Oracle Argus) and for integrated tools for data extraction and analysis (e.g., Business Object).
Experience Required

Minimum 5 years of experience in Pharmacovigilance or Clinical Data Management.

Education

Degree in pharmacy, pharmaceutical chemistry, biological sciences, biomedical engineering, informatics or statistical sciences.

Languages

Fluent English.

Technical Skills
  • Excellent data analytics skills, document management in a GxP environment (e.g., PSMF), principles of Computer System Validation (CSV), technical and IT capabilities.
  • In-depth knowledge of standard IT tools used in Pharma big data analytics.
  • Integration of different systems.
  • Ability to work in a dynamic, research-oriented group with several concurrent projects.
  • Self-educated and up-to-date with all IT systems developments to ensure related implementation and innovation.
  • Vault SafetyDocs from Veeva.
Soft Skills
  • Attention to details
  • Communication skills
  • Strategic thinking
  • Quality orientation
  • Decision making
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

  • Global Pharmacovigilance Digital Innovation

    3 giorni fa

    Parma, Italia Chiesi Farmaceutici A tempo pieno

    **Date**: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...

  • Global Pharmacovigilance Digital Innovation

    2 giorni fa

    Parma, Italia Chiesi Group A tempo pieno

    Who we are looking forPurposeLead, promote, and accelerate the innovation of PV technologies.Serve as the primary point of contact for the Pharmacovigilance community regarding the introduction, validation, training, and maintenance of tools for PV document management (e.g., electronic safety document management systems, front-end solutions, robotic process...

  • Global Pharmacovigilance Digital Innovation

    2 ore fa

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

    Global Pharmacovigilance Digital Innovation & Technologies ManagerTeam: 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...

  • Global Pharmacovigilance Digital Innovation

    1 giorno fa

    Parma, Italia Chiesi Group A tempo pieno

    Who we are looking for Purpose Lead, promote, and accelerate the innovation of PV technologies. Serve as the primary point of contact for the Pharmacovigilance community regarding the introduction, validation, training, and maintenance of tools for PV document management (e.g., electronic safety document management systems, front-end...

  • Global Pharmacovigilance Digital Innovation

    1 giorno 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...

  • Global Pharmacovigilance Operations Manager

    1 settimana 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 Documents Specialist

    6 giorni fa

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

    Key Responsibilities:• Support the Coordinator in global planning for pharmacovigilance documents.• Develop, consolidate, update, and distribute aggregates for global products with cross-functional teams.• Ensure compliance monitoring for PSURs/PBRERs and DSURs submitted for global products/molecules under development.• Lead cross-functional working...

  • Global Pharmacovigilance Operations Manager Air

    7 giorni 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

    1 settimana fa

    Parma, Italia Chiesi Farmaceutici A tempo pieno

    **Date**:5 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...

  • Global Pharmacovigilance Operations Manager Air

    5 giorni 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 Document Developer

    2 giorni fa

    Parma, Emilia-Romagna, Italia Chiesi Farmaceutici S.P.A. A tempo pieno

    About the JobChiesi Farmaceutici S.P.A. is seeking a skilled professional to support the development of wide-ranging pharmacovigilance documents for assigned global products within specific therapeutic areas.Main ResponsibilitiesAggregate Reports: Develop, consolidate, update, and distribute aggregate reports for global products in collaboration with...

  • Global Pharmacovigilance Operations Manager Air

    2 giorni fa

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

    Global 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...

  • Global Pharmacovigilance Operations Manager AIR

    2 giorni 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

    6 giorni 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...

  • Global Pharmacovigilance Operations Manager AIR

    1 settimana 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

    5 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...

  • Global Pharmacovigilance Operations Manager Air

    2 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,...

  • Pharmacovigilance Operations Specialist

    4 giorni 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...

  • Pharmacovigilance Medical Writer

    3 settimane fa

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

    Job SummaryWe are seeking a highly skilled Pharmacovigilance Medical Writer to join our team at Chiesi Group. As a key member of our cross-functional team, you will be responsible for developing a wide range of pharmacovigilance documents for our global products.Main ResponsibilitiesAggregate (PBRERs, PADERs, DSURs, ACOs) development and submission to Health...

  • Pharmacovigilance Document Developer

    2 settimane fa

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

    Job SummaryWe are seeking a highly skilled Pharmacovigilance Document Developer to join our team at Chiesi Group. As a key member of our cross-functional team, you will be responsible for developing a wide range of pharmacovigilance documents for our global products.Main ResponsibilitiesAggregate development and submission to Health AuthoritiesCompliance...