Facilities and Safety Officer
4 weken geleden
We are seeking an Associate Global Safety professional to join the Local Pharmacovigilance (Patient Safety) department of our Dutch affiliate in Breda.
You will support the team by managing tasks assigned to the Netherlands safety group within the Safety Database, specifically focusing on resolving action items related to Patient Support Programs (PSPs), clinical trials (CT), and spontaneous reports (SP).
PSPs involve third-party nurses visiting patients at home to explain the use of our products or, in some cases, administer them. Adverse events reported during these programs are investigated with the help of additional information from the prescribing healthcare professionals (HCPs) who enrolled the patients.
Manage approximately 50 letters weekly (volume may vary), primarily addressed to Dutch HCPs.
Ensure the timely submission of reportable adverse drug reaction reports and distribute periodic safety or urgent safety communications as required by local regulations and internal procedures.
Work with the Safety Manager and Senior Safety Associate to maintain high local operating performance standards and reporting compliance for adverse event cases and periodic safety reports.
Support the resolution of local issues through corrective and preventive actions (CAPAs) and related activities.
Help ensure local quality assurance measures are in place to maintain inspection readiness.
MBO+ or HBO degree.
Ability to follow standardized English procedures.
Fluency in Dutch and English (spoken and written).
Team-oriented mindset.
Duration: 1-year contract with the possibility of extension
Setup: Full-time, with one day per week in the office
Language Requirements: Fluency in English and Dutch
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Safety Officer
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Breda, Nederland Panda International Voltijd € 250We are seeking an Associate Global Safety professional to join the Local Pharmacovigilance (Patient Safety) department of our Dutch affiliate in Breda. Key Responsibilities You will support the team by managing tasks assigned to the Netherlands safety group within the Safety Database, specifically focusing on resolving action items related to Patient...
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