Gpv Operations Unit Head, Care

4 giorni fa

EmiliaRomagna, Italia Buscojobs A tempo pieno

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, 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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