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Gpv Operations Unit Head, Care
1 mese fa
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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