Gpv Operations Unit Head, Care
3 settimane fa
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.
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.
Who we are looking for
Purpose The "Global Pharmacovigilance Operations Unit Head, Care" supports the Global Pharmacovigilance Team (within R&D) in the execution and oversight of premarket and postmarket pharmacovigilance operations activities within the "Care" Business Unit.
Main Responsibilities • Collaborate with Global PV Operations Department Head in planning GPV Ops activities, maintaining him/her updated on projects status and escalating in case of issues
• Provide input within the Care Business Unit
• Supervise the activities of Specialists in the Care Business Unit within GPV Ops and follow their performance and development plan
• Oversight studies, organized data collections, and Compassionate use/expanded access programs, including non-interventional studies (Post-Authorisation Safety Studies [PASSs] included), revising/drafting relevant documents
• Monitor PV operations performance of CROs involved in clinical studies and escalate in case of issues
• Provide assistance to the Integration Manager in the integration phase of company/products acquisition as well as during due diligences
• Manage projects that foresee a collaboration model with other companies in a Global exclusive license agreement, setting up processes and exercising the oversight on their activities
• Participate as a member to regulatory submission and response teams
• Provide inputs on global SOPs and WIs and other controlled documents
• Support other PV activities, both at global and affiliate level
• Be responsible for cross-functional projects and processes
• Participate in audit and inspection activities
• Maintain compliance to relevant regulations, policies and procedures
• Participate to the internal departmental meetings and project-specific teams
• Represent GPV department in cross-functional corporate teams and projects
Experience Required • Minimum 10 years of experience in R&D within Pharmaceutical and/or Biotechnology industry, with at least 6 years of experience in Pharmacovigilance
Education • Master degree in science, medicine, biology, pharmacy or related fields, PhD or similar preferred
Languages Technical Skills • Awareness of EU pharmacovigilance legislation and the principles of global pharmacovigilance requirements including knowledge of PV quality systems and regulatory requirements across US and other countries and regions
• Knowledge of EMA GvP modules
• Technical writing capability
• Up-to-date knowledge of local/ global CT regulations and respective need for compliance (e.g. Good Clinical Practice)
• Knowledge of MedDRA coding dictionary and its principles
Soft Skills Emotional and social intelligence
Planning and organizational skills
Strategic thinking
Problem solving
Stress management
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.
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