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job location Job Location:

Italy

 

Pharmacovigilance QA Consultant

Requested Languages:

English
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job at pqe

We are a service provider company, leader in the Pharmaceutical and Medical Device sectors. With more than 800 employees and 20 subsidiaries all over the world (Europe, Asia and the Americas), joining PQE means to join a multicultural and challenging company in which you will be involved in international projects, working with colleagues from all over the world.

Due to our constant growth in Italy, we are looking for a new PV Auditor - Freelancer.

The PQE Pharmacovigilance Centre offers the most comprehensive services dedicated and tailored to MAH, Sponsors, CROs and PV Service Providers. Our service excellence is achieved through a team with more than 10 years of experience in this field.



    RESPONSIBILITIES:
    Responsibilities include, but are not limited to, the following:
  • Development of pharmacovigilance audit plans
  • Execute PV audits to internal processes, commercial partner, affiliate and services provider.
  • Drafting audit reports and following-up corrective action and preventative action (CAPA) plans
  • Drafting and updating relevant section of the Pharmacovigilance System Master File
  • Drafting and revise SOPs and WIs related to pharmacovigilance and QA processes
  • Support clients during competent authorities’ inspection
  • Provides PV compliance and performance metrics
  • Administers and regularly report performance assessments related to pharmacovigilance processes
  • Provides pharmacovigilance representation during QA/PV team meetings and other cross-functional initiatives related to quality, standards and training.
    REQUIREMENTS:
  • Technical degree (Medicinal Chemistry, Biology, Pharmacy, etc)
  • English: Fluent
  • 3+ years of experience in Pharmacovigilance area
  • Availability to travel up to 70%
  • Experience in auditing activities
  • Deep knowledge of European and International PV regulation
  • Excellent interpersonal relations

If interested, please send your resume clicking the button on the left of this page.
Our collaborators are engaged, developed, challenged and well-rewarded for performance. We recognize the importance of leadership at all levels of our organization in order to succeed in a challenging business environment, and we are committed to providing practical processes and programs to identify, develop and inspire all our current and future leaders.


job at pqe