GPV Standards & Training Specialist

Date:  29 Aug 2024
Department:  Global Pharmacovigilance
Team:  R&D, Pharmacovigilance & Regulatory Affairs
Job Type:  Direct Employee
Contract Type:  Permanent
Location: 

Europe, 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

Responsible for maintaining the Global PV System & Standards.

Main Responsibilities

- Management of Standard Operating Procedures and Working Instructions:

  • To supervise and review the PV Standard Operating Procedures and Working Instructions planning; 
  • To maintain the distribution  matrix related to GPV procedures applicable to affiliates and PV Service Providers;
  • To act as GPV EDMS system Coordinator, including verifying technical details of procedures before initiating the workflow on the system;
  • To guide the PV System and Standards ensuring that the corporate guidelines for procedures management are followed by GPV Personnel;
  • To overview the review/release phases of corporate PV procedures with the R&D QA Pharmacovigilance Unit.

- Management of training activities pertinent to GPV, Affiliates and CROs/Partners:

  • To manage the  PV basic training material as well as periodic control of its completion;
  • To manage the creation of Functional Modules and Professional Figures for GPV, Affiliates and PV Service Providers (as applicable) for the update in C-Learning;
  • To manage the maintenance of training plans for GPV, Affiliates and PV Service Providers (as applicable); 
  • To supervise the registration and archival of training forms in C-learning system for GPV, Affiliates and PV Service Providers (as applicable);

- Supervision of GPV Personal Files and Job Descriptions update;

- Support in the preparation and management of PV inspections and audits as well as on CAPA Plan definition and records creation in Trackwise.

 

Experience Required

3-5 years of work experience in global pharmaceutical companies 

Education

Master Degree in life sciences, pharmacy or related fields

Languages

English (fluent).

Knowledge of any additional language (German, French) is preferred.

Technical Skills

  • Training and meetings organisation;
  • Basic knowledge of drug development process in a pharma industry;
  • Excellent communication and analytical skills.
  • Being extrovert with excellent networking skills;
  • Proven ability to manage details, solve problems and keep multiple tasks/ projects on track;
  • Ability to organize and prioritize tasks both; individually and across team to achieve established deadlines;
  • Expertise in scheduling and organizing activities, with proven ability to coordinate people.

Soft Skills

  • Communication skills
  • Decision making
  • Time management
  • Attention to details

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.

DISCOVER ALL OUR JOB OPPORTUNITIES