Randstad Belgium

www.randstad.be

1 Job

600 Employees

About the Company

Randstad has been active in the Netherlands since 1960 and in Belgium since 1965. We started out purely as a temporary employment agency, but have gradually developed more and more activities:

* Ausy, a Randstad company or ICT specialists, engineers, and specialists in life sciences, HR, finance and sales & marketing

* HR services such as outplacement, assessments,...

In short, Randstad dominates all areas of the employment market.

Listed Jobs

Company Name: Randstad Belgium
Job Title: Regulatory Affairs Specialist
Job Description: Job Title: Regulatory Affairs Specialist Role Summary: Manage and report safety data for clinical and post‑marketing drugs, ensuring compliance with global pharmacovigilance regulations and supporting timely regulatory submissions. Expectations: Deliver accurate and timely adverse event reporting, maintain database integrity, and uphold rigorous pharmacovigilance standards within R&D. Key Responsibilities - Compile and organize adverse event data and narratives, addressing short‑ and long‑term drug effects. - Conduct safety assessments, determining seriousness, causality, and expectedness in line with regulatory standards and product labeling. - Enter and maintain adverse event records in the safety database and tracking system. - Assist in preparing regulatory submissions, ensuring adherence to required reporting timeframes. - Aggregate safety information from healthcare professionals and consumers for regulatory dossiers. - Document potential adverse events that do not meet formal database entry criteria. Required Skills - Strong organizational and analytical abilities. - Detail‑oriented with meticulous data handling. - Comprehensive understanding of pharmacovigilance concepts and regulatory reporting requirements. - Proficiency in documentation and investigative procedures. - Ability to meet strict deadlines and quality standards. Required Education & Certifications - University/Bachelor’s degree or equivalent in life sciences, pharmacology, or related field. - 2–4 years of experience in drug and product safety operations or a related regulatory affairs role. - Certifications in pharmacovigilance or regulatory affairs (preferred but not mandatory).