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)
