Local Qualified Person for Pharmacovigilance Specialist

2 maanden geleden

Zwolle, Overijssel, Nederland Parexel Voltijd

Purpose and Scope

Parexel is a leading global biopharmaceutical services company that provides a comprehensive suite of services to help clients transform scientific discoveries into new treatments. As a key member of our Pharmacovigilance team, we are seeking a highly experienced and skilled Local Qualified Person for Pharmacovigilance (QPPV) to join our network of freelancers.

Key Responsibilities

  • Expert knowledge of local pharmacovigilance legislation and regulations in assigned territories.
  • Minimum of 7 years' experience in managing or implementing pharmacovigilance systems, including quality assurance.
  • Documented experience in all aspects of pharmacovigilance to fulfill the responsibilities of the Local QPPV.
  • Extensive knowledge of global pharmacovigilance regulations and guidelines, including GVP and GCP.
  • Experience in pharmacovigilance safety risk management, including clinical trials, post-market pharmacovigilance, safety case processing, safety reporting, and safety systems.

Requirements and Qualifications

To be successful in this role, you will have:

  • A strong understanding of local and global pharmacovigilance regulations and guidelines.
  • Excellent communication and project management skills.
  • Ability to work independently and as part of a team.
  • Strong analytical and problem-solving skills.
  • Experience working with electronic safety reporting systems and other pharmacovigilance software.

What We Offer

Parexel offers a dynamic and challenging work environment, with opportunities for professional growth and development. As a member of our Pharmacovigilance team, you will have the opportunity to work on a variety of projects and contribute to the success of our clients.

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