GPV PSMF & COMPLIANCE SR SPECIALIST

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 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 support GPV in ensuring that Company's pharmacovigilance system is consistent with the regulatory requirements in terms of structure and performances Main Responsibilities To evaluate relevant pharmacovigilance regulations, guidelines and recommendations for their applicability to the Company's PV system and support all concerned functions worldwide in the implementation in their areas; To ensure that the PSMF is timely and properly updated by collecting all the requested document from concerned stakeholders, and advices the Head of Global PV & EU-QPPV and other concerned stakeholders on potential changes and amendments; To contribute in the definition of pharmacovigilance KPIs and to propose improvements in their monitoring, evaluation and reporting so to increase the efficiency of the PV system; To track metrics and trends as well as compliance issues and their resolution on a periodic basis; To deliver reports related to the PSMF and KPIs to concerned stakeholders for evaluation of the Global PV system status and performance; To maintain GPV business continuity plan;       Experience Required Minimum 5 years of experience in international Pharmacovigilance within Pharmaceutical and/or Biotechnology industry and/or Contract Research Organisation Education Master Degree in life sciences, pharmacy or related fields Languages English fluent  Technical Skills Soft Skills Communication skills Team working Decision making Problem solving 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.