Hybrid Pharmacovigilance & Regulatory Affairs Officer (Benelux)

ALK; Almere; Hybrid; EUR 55,000 - 75,000; Full time

Job summary

A pharmaceutical company in Almere, Netherlands is seeking a Pharmacovigilance & Regulatory Affairs Officer to support key safety and registration processes within a regulated environment. The ideal candidate must be fluent in Dutch and English and have 1-3 years of experience in pharmacovigilance or regulatory affairs. Responsibilities include recording safety information, regulatory submissions, and translation of product information. This role offers a chance to contribute to the safe availability of medicines with a possible work-from-home option.

Qualifications

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

Responsibilities

• Record and process safety information from the Netherlands, Belgium, and Luxembourg.
• Support daily pharmacovigilance activities and maintain the local PV system.
• Prepare and maintain regulatory submission documents in line with EU regulations.
• Translate English core Product Information into Dutch, French, and German.
• Handle regulatory documentation for medical devices across multiple countries.

Skills

Fluent in Dutch

Fluent in English

Good communication skills

Accurate working style

Well-organized working style

Job description

A pharmaceutical company in Almere, Netherlands is seeking a Pharmacovigilance & Regulatory Affairs Officer to support key safety and registration processes within a regulated environment. The ideal candidate must be fluent in Dutch and English and have 1-3 years of experience in pharmacovigilance or regulatory affairs. Responsibilities include recording safety information, regulatory submissions, and translation of product information. This role offers a chance to contribute to the safe availability of medicines with a possible work-from-home option.