Global Safety Compliance Administrative Breda • SIRE Life Sciences

The Client 
Our client is a leading global biotechnology company that focuses on discovering, developing, manufacturing, and delivering innovative human therapeutics. The company's mission is to use advanced science and technology to address serious diseases, including cancer, cardiovascular conditions, and autoimmune disorders.

The Role 

In this role, you are responsible for ensuring patient safety by managing and reporting adverse events (AEs) related to our client’s products in the Netherlands. An adverse event refers to any unexpected side effect a patient experiences while using a medication. As part of the local pharmacovigilance team, you will monitor and process these reports, which may come from patient support programs, clinical trials, or spontaneous reports from healthcare professionals or patients

• Review and track any reports of side effects or issues related to the client’s products, ensuring that all incidents are recorded accurately in the safety database.

• Handle adverse events that arise during homecare programs, ensuring timely follow-up and communication with healthcare professionals to gather additional information when necessary.

• Reach out to HCPs via letters to request further details on adverse events, ensuring clear and effective communication, and follow up on any responses to complete the necessary documentation.

• Make sure that all adverse event reports and safety communications are submitted on time and in line with local regulations, as well as internal company policies and procedures.

• Ensure that additional risk minimization strategies and safety measures are communicated to relevant parties, helping to reduce potential risks associated with the products.

• Work closely with the Safety Manager and other team members to uphold safety standards, address any local safety challenges, and contribute to problem-solving efforts when needed.

• Ensure that all safety processes, documentation, and reports are up to standard, maintaining readiness for any inspections or audits by regulatory bodies.

• MBO+ or HBO degree (vocational or higher education) with a strong administrative background, including experience with Office applications.
• Fluency in Dutch and English for effective communication and documentation
• Strong ability to handle information accurately, with excellent verbal and written communication skills to interact with healthcare professionals and internal teams.
• Ability to collaborate effectively with team members, take initiative, and seek help when faced with unfamiliar situations. 
• Proficient in basic computer skills and database use, with a customer-focused approach when interacting with healthcare professionals and patients.

54534