Medical Safety Leader - Mechelen, BE/Basel,CH/Romainville, FR

Job description

Pleased to meet you, we are Galapagos, a dynamic fast growing Biotech company. We’re in the business of changing lives.


Galapagos’ mission is to make a lasting positive contribution to society through discovery of innovative therapies for diseases with large unmet medical need. Galapagos seeks to develop a robust portfolio of therapies that have the potential to revolutionize existing treatment paradigms. The company’s ambition is to become a leading global biopharmaceutical company, focused on the discovery, development and commercialization of innovative medicines to improve patients’ lives. Galapagos’ historic focus on developing first-in-class medicines based on the discovery of novel targets in inflammation and fibrosis has led to the successful launch of our first medicine in rheumatoid arthritis in 2020 and in ulcerative colitis in 2021. The pivotal study in Crohn’s Disease is fully recruited and we expect topline data and potential approval in this new indication in a couple of years.

Galapagos is now entering an exciting new chapter to expand and diversify its pipeline for the future, starting with oncology, specifically CAR-T cell-therapy, a transformative treatment of different types of cancer. Through the combined acquisitions of CellPoint and AboundBio, we are propelling ourselves into next-generation cell therapies. CellPoint brings a novel, decentralized point-of-care cell therapy manufacturing model, which has the potential to offer efficient, 7-day time to treatment and avoids complex logistics, resulting in potential better patient outcomes and broader access. AboundBio’s cutting-edge fully human antibody-based platform provides access to a research engine for next generation multi-targeting CAR-Ts that have the potential to deliver deeper and durable clinical responses and that will be developed using CellPoint’s decentralized model.


  We are looking for a Medical Safety Leader - Basel,CH/Mechelen,BE


Scope of the job:

You are responsible for the 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 (including financial oversight)
  • 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 all sources and collaborate with the PV vendor to process ICSRs and ensure expedited reporting requirements are met
  • Review study-specific Safety Project Plan for assigned clinical studies and post-marketed Safety Project Plan 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 etc
  • Lead or contribute to the creation and review of the Safety parts of certain compound related documents – Investigator’s Brochure, Safety Risk Log, etc
  • Author and oversee the creation and submission of Development Safety Update Report (DSURs), Periodic Benefit/risk evaluation report (PBRER) and Risk Management Plans (RMPs) for assigned compounds


Job requirements

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…!