Gpv Operations Unit Head, Care

3 settimane fa

Parma, Italia Chiesi Farmaceutici A tempo pieno

**Date**:4 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**
- 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**
- English fluent
**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, chal

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