Date: 18 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

• To design, drive, and oversee cross-functional projects within GPV and between functions aiming at increasing the value that GPV can bring to the Chiesi business.
• To oversee signal and risk management activities for Chiesi products to ensure patient safety and compliance with global regulatory and quality standards.
• To oversee and maintain robust procedures for the planning, preparation, and submission of high-quality aggregate safety reports, in compliance with requisite global and local regulations and requirements.

Main Responsibilities

• Provide leadership and direction to cross-functional report authors and contributors
• Interact and communicate effectively both internally and cross-functionally in a highly matrixed environment
• Responsible for strategic oversight of aggregate safety reports for investigational and marketed products globally
• Ensure aggregate reporting processes and procedures are complete and compliant with current regulations globally and internal QA
• Manage the CoE team including the distribution of assignments, prioritization of tasks, personal objectives, and mentorship/training as required
• Act as safety lead for the overall benefit-risk strategy of the Chiesi product portfolio
• To provide input to the safety signal management, input to safety-related global labelling changes, and safety-related contributions to responses to regulatory authority
• To participate in safety governance committees
• To manage the CoE budget for projects, activities, and people development
• To drive an innovative way of working in GPV as per the company culture (matrix)

Experience Required

Minimum 5 years of experience in pharmacovigilance, with theoretical and practical knowledge of Pharmacovigilance at both global and local scales. Education

Master's degree in science, PhD or similar preferred Languages

English fluent Soft Skills

• Conflict management
• Leadership and social influence
• Analytical skills
• Planning and organizational skills
• Strategic thinking

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.