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Pharmacovigilance and Patient Safety Associate

1 week geleden

Breda, Noord-Brabant, Nederland Panda International Voltijd € 250

Panda International seeks an experienced Pharmacovigilance and Patient Safety Associate to join our team in Breda. In this role, you will be responsible for supporting the team by managing tasks assigned to the Netherlands safety group within the Safety Database.

You will focus on resolving action items related to Patient Support Programs (PSPs), clinical trials, and spontaneous reports. PSPs involve third-party nurses visiting patients at home to explain the use of our products or administer them in some cases. Adverse events reported during these programs are investigated with additional information from prescribing healthcare professionals who enrolled the patients.

You will manage approximately 50 letters weekly addressed to Dutch HCPs, ensuring timely submission of reportable adverse drug reaction reports, and distributing periodic safety or urgent safety communications as required by local regulations and internal procedures.

Key Responsibilities:
  • Manage tasks assigned to the Netherlands safety group within the Safety Database.
  • Resolve action items related to Patient Support Programs (PSPs), clinical trials, and spontaneous reports.
  • Ensure timely submission of reportable adverse drug reaction reports.
  • Distribute periodic safety or urgent safety communications as required by local regulations and internal procedures.
Requirements:
  • MBO+ or HBO degree.
  • Ability to follow standardized English procedures.
  • Fluency in Dutch and English (spoken and written).
  • Team-oriented mindset.

This position offers a 1-year contract with the possibility of extension, working full-time with one day per week in the office. Fluency in English and Dutch is essential.