Safety Officer

We 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 Support Programs (PSPs), clinical trials (CT), and spontaneous reports (SP).

Patient Support Programs (PSPs)

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.

• Identify relevant HCPs in the system and send letters to request further details regarding adverse events.
• Manage approximately 50 letters weekly (volume may vary), primarily addressed to Dutch HCPs.
• Distribute additional risk minimization measures (aRMMs) and process received follow-up correspondence.

Adverse Event Processing

• Perform accurate and timely local processing of all adverse events reported through letters, email, or phone.
• 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.
• Facilitate the exchange of adverse event information with functional service providers, following agreed processes.

Collaboration and Compliance

• 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.

Qualifications and Requirements

• MBO+ or HBO degree.
• Strong administrative skills with experience using Microsoft Office.
• Ability to follow standardized English procedures.
• Fluency in Dutch and English (spoken and written).
• Strong attention to detail.
• Effective communication and interpersonal skills.
• Team-oriented mindset.
• Proficiency in using computer systems, with some knowledge of databases.
• Proactive and able to seek guidance in unfamiliar situations.
• Customer-focused approach.

Practicalities:

Location: Breda

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

If you are interested in this opportunity, please send your CV to f.karampina@panda-int.com today- Interviews and offer can happen next week

Let's connect as soon as possible.

If you know someone who might be a good fit, feel free to introduce me to them. You can also refer a friend and earn €250,- for successful referrals.