Medical Safety Officer - Leiden (NL), Mechelen (BE) or Basel (CH)

Pleased to meet you, we are Galapagos, a dynamic growing Biotech company with offices across Europe and in US, headquartered in Mechelen, Belgium.

We are in the business of changing lives. Focusing on high unmet medical needs, we synergize compelling science, technology, and collaborative approaches to create a deep pipeline of best-in-class small molecules, CAR-T therapies and biologics in oncology and immunology. With capabilities from lab to patient, including a decentralized, point-of-care CAR-T manufacturing network, we are committed to challenging the status quo and delivering results for our patients, employees and shareholders.

We pioneer for patients. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists. We need the best-in-class. In other words, we need you : The ‘make-it-happener’.

We are looking for a (Senior) Medical Safety Officer.

Scope of the job

Reporting to the Medical Safety Operations Director, the (Senior) Medical Safety Officer is acting for global pharmacovigilance for Galapagos across the company portfolio of all investigational products.

Main responsibilities include ensuring operational compliance in clinical trials, overseeing safety vendors, and contributing to Galapagos' adherence to pharmacovigilance regulations. Additionally, the (Senior) Medical Safety Officer supports inspection readiness, provides support during audits and inspections, identifies, and leads process improvements and is open to provide support in additional processes like signal management.

In executing continuous quality control at different levels in the processes in place in the department, the Medical Safety Officer is actively contributing to company’s compliance to Pharmacovigilance regulations and ensuring the safety of all participants in Galapagos clinical studies.

Your role

• Ensure adherence to operational safety processes in assigned projects.
• Collaborate with external service providers to ensure Individual Case Safety Reports (ICSRs) from clinical trials are processed compliantly and ensure expedited reporting requirements are met.
• Coordinate the development of study-specific Safety Project Plans for assigned clinical studies and oversee their execution.
• Manage the development and submission of Development Safety Update Reports (DSURs) and periodic Line-Listings.
• Ensure compliance with regulatory requirements and timely submission of expedited and periodic reports.
• Oversee the safety part of the electronic Trial Master File (eTMF) in collaboration with Clinical Operations.
• Collaborate with Quality Management to ensure operational processes align with Galapagos' operational model.
• Work with external service providers to ensure pharmacovigilance services meet industry standards and regulatory guidelines.
• Support inspection readiness and provide support for audits and inspections.
• Identify, and lead process improvements within Safety Operations.
• Along with the Medical Safety Leader, contribute to the creation and review of safety sections within clinical studies documents (Clinical Study Synopsys/Protocols, Clinical Study Reports, Investigator’s Brochure, dRMP etc.)
• Represent the Medical Safety Department in cross-functional meetings or working groups as needed.