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Job Specifications

Regulatory Affairs Engineer - Drug & Product Safety Operations

About the Role

We are seeking a dedicated and meticulous Regulatory Affairs Engineer to join our Research & Development (R&D) team, specifically focusing on Drug & Product Safety Operations. In this crucial role, you will be instrumental in managing, organizing, and reporting safety data related to our clinical study and post-marketing drugs and products, ensuring strict compliance with global regulatory standards.

Key Responsibilities

As a Regulatory Affairs Engineer, your primary focus will be on the handling and reporting of adverse event data:

Adverse Event Management: Organize and compile data and narratives concerning adverse events, focusing on both short and long-term effects of drugs and products.
Safety Assessment: Review regulatory reporting requirements and prepare a preliminary assessment of adverse event seriousness, causality, and expectedness/listedness in strict accordance with regulatory guidelines and product labeling.
Database Entry & Maintenance: Input adverse event codes into the appropriate safety database. Maintain comprehensive adverse event files and tracking systems.
Regulatory Reporting: Assist with the preparation of adverse event reports for timely submission to regulatory agencies, ensuring adherence to required reporting timeframes.
Data Compilation: Compile and organize information on possible adverse events obtained from healthcare professionals and consumers. Gather and arrange cumulative safety data for submission to regulatory agencies.
Documentation: Document details of potential adverse events that do not meet the criteria for formal database entry.

Required Qualifications & Experience

Education: University/Bachelor's Degree or Equivalent is required.
Experience: Generally requires 2–4 years of relevant work experience, preferably within Drug & Product Safety Operations or a related Regulatory Affairs function.
Skills: Strong organizational skills, meticulous attention to detail, and a thorough understanding of pharmacovigilance concepts and regulatory reporting requirements.

Work Environment & Access

Job Function: R&D
Job Subfunction: Drug & Product Safety Operations
Site Access: This is primarily an Off-Site role with Limited Site Access (maximum of 20 days on-site).

Job Offer

As a consultant through Randstad Professionals, you'll find yourself in a dynamic and challenging environment with the security of a permanent contract and an attractive salary package.

Your benefits as a Randstad Professional Consultant:

Salary package: Competitive gross salary, depending on your expertise and personal situation.
Net compensation: An additional net compensation of €80 per month, on top of your net salary.
Mobility: The option of a company car (under certain conditions) with a fuel card (also for personal use) or an attractive mileage allowance.
Meal vouchers: Meal vouchers worth €140 per 20 days worked.
Benefits: Annual eco-vouchers of €250.
Vacation: Statutory holiday allowance, 13th-month salary, and 12 additional vacation days per year (ADV).
Insurance: Comprehensive hospitalization insurance with DKV and pension savings.
Growth & Development: Access to a wide range of training courses, fun activities, and career development opportunities to guide and boost your career.

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. Know more