Pleased to meet you, we are Galapagos, a dynamic fast growing Biotech company with offices in Europe in Belgium (Mechelen), Switzerland (Basel), France (Romainville), the Netherlands (Leiden) and in US, Boston.
We’re in the business of changing lives. In our quest to discover and develop life-improving medicines we go where no one has ever gone before.
In every challenge we face, we see new opportunities. We want to challenge the impossible. 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-happeners’.
We are lookingfor 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?
MD degree or equivalent (eg, DO or MB) require
5 years or more of clinical experience and / or Industry experience, with a focus on patient safety or prior pharmacovigilance experience preferred;
Deep knowledge of the specific therapeutic area is strongly preferred;
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.
What’s in it for you ?
You will be part of a fast growing and amazing company. As make-it-happener’ you will get all the support you need to make your job successful.
At Galapagos we aim to recruit the best people, who stand out among their peers, with integrity and excellent interpersonal and organizational skills.
Our employees are the strength behind Galapagos, a highly motivated team, eager to maintain Galapagos’ leading position and achieve breakthroughs in pharmaceutical research.
Galapagos offers a competitive remuneration package and a dynamic work environment.
We are Galapagos : together we can make it happen !