Pharmacovigilance & Regulatory Affairs Officer

Location: The Netherlands
Working hours: 40 (possible to work from home 2 days), PV 20 hours & RA 20 hours
Department: Medical
Reports to: Quality and Regulatory Affairs Manager

Position Summary:
As Pharmacovigilance & Regulatory Affairs Officer you will supports the daily activities of Pharmacovigilance (PV) and Regulatory Affairs (RA) within a regulated environment. This role focuses on the correct processing of safety information and the maintenance of registration files. You will work in accordance with applicable laws and regulations, as well as internal procedures. Together, you will contribute to the safe and timely availability of medicines for patients.

Key Responsibilities PV
• Record, process and follow up on safety information (adverse events, product complaints) from the Netherlands, Belgium and Luxembourg.
• Support the NPPV and deputy-NPPV Benelux in day-to-day pharmacovigilance activities, including projects, SOP updates, trainings and PV agreements with external partners.
• Maintain the local PV system, including case files, tracking systems and archiving in line with local SOPs.
• Request, document and track follow-up information for Individual Case Safety Reports (ICSRs) in collaboration with reporters and GSP.
• Support internal and external audits and inspections.

Key Responsibilities RA
• Perform regulatory affairs activities for the Benelux, the UK and Ireland.
• Prepare, submit, maintain and archive registration dossiers, SPCs, labelling and mock-ups in line with EU and local regulations.
• Translate English core Product Information into Dutch, French and German, and maintain local Product Information and short product texts.
• Manage submission, maintenance and archiving of NPP files in the Netherlands.
• Handle regulatory documentation for medical devices across the Benelux, UK and Ireland.

Qualifications:
• HBO-level
• Fluent in Dutch and in English. Good communication skills.
• Basic knowledge of EU pharmacovigilance and regulatory affairs legislation
• Experience (1-3 years) in PV and/or RA role, preferably within the pharmaceutical industry.
• Accurate, well-organized and compliant working style in a regulated environment.

Ready to Drive Change? Do you enjoy working accurately, thrive in a regulated environment, and get energized by correctly applying guidelines and procedures? Do you want to contribute to safe and timely access to medicines in a combined role as a Pharmacovigilance and Regulatory Affairs Officer? Then we invite you to apply.