Global Pharmacovigilance Operations Manager AIR

Global Pharmacovigilance Operations Manager AIR

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. 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.

In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.

Purpose

The “Global Pharmacovigilance Operations Manager, Air” supports the Global Pharmacovigilance Team (within R&D) in the execution and oversight of pharmacovigilance operations activities within the “Air” Business Unit.

Main Responsibilities

• Collaborate with Global PV Operations Unit Head, Air in planning GPV Ops activities on specific projects within the AIR business area
• Provide input within the AIR Business Unit
• Manage studies, organized data collections, and Compassionate use/expanded access programs, including non-interventional studies (Post-Authorisation Safety Studies included), reviewing/drafting relevant documents
• Monitor PV operations activities of CROs involved in clinical studies
• 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 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

Experience Required

Minimum 7 years of experience in R&D within Pharmaceutical and/or Biotechnology industry, with at least 3 years of experience in Pharmacovigilance.

Education

Master degree in science, medicine, biology, pharmacy or related fields.

Languages

Technical Skills

• Awareness of EU pharmacovigilance legislation
• Technical writing capability
• Up-to-date knowledge of clinical trial requirements

Soft Skills

• Planning and organizational skills
• 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.