Medical Safety Leader
Galapagos
Mechelen, Belgium
5 dagen geleden

Pleased to meet you, we are Galapagos, a dynamic fast growing Biotech company with offices in Europe.

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 - 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
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