Medical Safety Manager - Basel, Switzerland or Romainville, France
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 Manager.
Scope of the job:
Acting for global Medical Safety of Galapagos across the company portfolio of all investigational products, focusing in the processes control, department’s tool management, SOP writing/cycle management/implementation, interactions with the country organizations, training to the Medical Safety Department team members as well as to all involved in the Medical Safety activities actors from other Galapagos Departments or external vendors. Executing continuous quality control at different levels of the processes in place in the department, actively contributing to company’s compliance to the Pharmacovigilance regulations and by extension to the guarantee of the safety of all participant’s in Galapagos clinical studies. Serving as main contact, insuring the smooth and close collaboration between Medical Safety Department and the Quality&Compliance Department, Training Department and IS Division of Galapagos.
- Ensure that all operational processes at Medical Safety Department are followed
- Identify the needs of SOP/WI of Medical Safety Department, initiate and coordinate their writing and implementation
- Collaborate with the external service providers delivering pharmacovigilance services, including quality control of the ICSRs, and any other Safety related documents, ensure PV vendor oversight
- 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 these activities are executed accordingly
- Integrate the safety scientific component to build 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 )and Periodic Benefit/risk evaluation report (PBRER)
- Guarantee the compliance with regulatory requirements - timely execution of all submissions of expedited and periodic reports - in implementing and performing regular control and KPIs follow up
- In collaboration with the IS, identify, evaluate, implement and maintain the tools needed for the functioning of the Medical Safety Department. Insure that all team members are appropriately trained and the necessary access are granted to all relevant actors
- In collaboration with the Clinical Operations, is in charge of the Phamacovigilance part of the eTMF
- Setup procedures and coordinate PSMF development in collaboration with the EU-QPPV
- Create and maintain interfaces with country organizations on all PV related matters
- Maintain Risk management plan for approved drugs
- Provide trainings, in collaboration with the Training Department, to all concerned Galapagos Departments and external vendors
Who are you?
- Master / Phd degree with 5 years relevant experience in drug safety
- Able to fluently read, write, understand and communicate in English
- The regulatory landscape has no secrets for you, in particular for PV-related matters
- Proven ability to drive the change, improve processes and manage people in drug safety
- 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…!