Medical Safety Leader - 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 Medical Safety Leader.

Scope of the job

Responsible for global pharmacovigilance activity of dedicated Galapagos investigational products portfolio, including review and analysis of safety data from non-clinical and clinical trials, quality control of ICSRs, identification and management of safety signals, management of benefit-risk profile of the assigned compounds, scientific review of internal and external documents.

Your role

• Ensure that all operational processes, regarding pharmacovigilance, are followed in assigned project
• Manage the external service providers delivering pharmacovigilance services, up to industry standards as per regulations and guidelines, including financial follow up, quality control of the ICSRs, PSURs and any other Safety related documents, compliance with regulatory requirements (timely submission of expedited and periodic reports)
• Perform medical review and provide medical advice on safety-related aspects associated with the assigned compounds
• Chair regular meetings of the Safety Management Teams overseeing the compound Safety profile
• Review and validate ICSRs from ongoing clinical studies and collaborate with the External service provider to process the ICSR, ensure expedited reporting requirements are met
• Review of a study-specific Safety Project Plan for assigned clinical studies across the portfolio, and ensure oversight on the activities executed accordingly
• Integrate the safety scientific component to build up a strategic framework for clinical development plans
• Contribute to the creation and review of the Safety parts of certain clinical study related documents – Clinical Study Synopsys/Protocols, Clinical Study Reports
• Contribute to the creation and review of the Safety parts of certain compound related documents – Investigator’s Brochure, dRMP, …
• Initiate, author, oversight and collaborate with the Regulatory Leader to create and submit the Development Safety Update Report (DSURs)

Who are you ?

• 7 years or more of clinical experience and/or Industry experience, with at least 3 years of these in patient safety or pharmacovigilance ;
• Previous experience in phase 1 to 3 clinical trials strongly preferred.
• Prior Oncology experience strongly preferred, either in clinical practice or drug safety
• Immunology experience would also be beneficial plus
• Experience with interactions with major Regulatory Agency is preferred;
• Effective team member who takes ownership;
• Demonstrated attention to detail, strategic thinking and problem solving skills
• Able to work under stress, demonstrating initiative and flexibility.
• MD degree or equivalent (eg, DO or MB) required

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…!