Head Of Global Pharmacovigilance Center Of Excellence Parma

Head Of Global Pharmacovigilance Center Of Excellence
Parma
Emilia Romagna, Parma

Head of Global Pharmacovigilance Center of ExcellenceTeam: 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.

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.

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.

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

EducationMaster's degree in science, PhD or similar preferred.

LanguagesSoft SkillsConflict managementLeadership and social influenceAnalytical skillsPlanning and organizational skillsStrategic thinkingWhat 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