Global Pharmacovigilance Digital Innovation

3 settimane 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**
- Minimun 5 years of experience in Pharmacovigilance or Clini

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