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.

Who are you ?

Education (add qualification if relevant) & experience:

• Pharmacist, or a Life Sciences degree
• 3+ (5+ for senior) years of experience in similar position, including experience with working in a structured environment as a member of program/compound teams and in general successful working in a matrix environment.
• Experience in drug development, in a biotech or pharmaceutical company.
• Experience interacting with stakeholders with different backgrounds and ability to adapt to corporate culture are essential.
• Previous safety science experience in addition to safety operations is a plus.
• Experience with CAR-T or other cell therapy or gene therapy is a plus.

General skills:

• Broad knowledge of pharmacovigilance needs within a drug development environment
• Sound knowledge of general drug development process
• Excellent team player, able to deliver against a tight deadline and in a demanding environment
• Flexible mindset, ability to adapt to rapidly changing environment
• Very good technical and organizational skills
• Communication Skills
• Excellent writing and communication skills both towards team members within the company as towards external contacts
• Ability to negotiate and influence
• Sound knowledge of ICH (International Council on Harmonisation of Technical Requirements), GCP (Good Clinical Practice), and other regulatory requirements applicable in the pharmacovigilance domain

Language Skills:

Fluent in English, working knowledge of other international languages beneficial.

What’s in it for you ?

At Galapagos, we prioritize your continuous growth and development, fostering a culture of empowerment. Our employees are the driving force behind our mission to lead in pharmaceutical research and innovation.

We offer a competitive compensation package and a supportive work environment with strong focus on your health and well-being. Join us in our journey towards sustainability, as we strive to make a lasting impact on both the industry and the planet.

Galapagos is dedicated to ensuring equal employment opportunities. Our hiring decisions are based on merit, considering qualifications, skills, performance, and achievements. We strictly prohibit discrimination against any employee or job applicant based on personal characteristics that are unrelated to their job.

We are Galapagos : together we can make it happen…!