41 days ago on novimmune.com

Drug Safety Physician

NovImmune SA

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 Please refer to JobSuchmaschine in your application

Drug Safety Physician

Career Opportunity

Drug Safety Physician

Novimmune SA is a drug discovery and development company located in Plan-les-Ouates and Basel, Switzerland, that focuses on developing therapeutic monoclonal antibodies for inflammatory diseases and immune-related disorders. The pipeline is a balance of preclinical and clinical compounds, specific for clinically validated and novel targets. Each of these portfolio products has the potential of becoming a medicine for multiple medical conditions due to the intrinsic mechanism of action. Five of these compounds are currently in early clinical development with the three most advanced in clinical Phase II. The company has also been purposefully targeting a number of orphan drug indications, with the express hope of eventually providing safe and effective treatment options to some of the often neglected populations suffering from rare diseases.

Novimmune is seeking a Drug Safety Physician, based in Basel, who will manage safety information and medical review in clinical trials for a drug candidate or one (or more) of its indications.

Major responsibilities:
  • Manage all aspects of safety related to products in development, including single case assessment, aggregate reporting, signal detection, risk management throughout the life cycle.
  • Establish safety analyses including medical evaluation, risk management, signal detection using epidemiology and other input as appropriate in order to ensure that adequate measures based on safety findings are taken.
  • Support the Clinical team in bringing the safety expertise in interaction with Heath Authorities, Data Monitoring Committees and Investigators.
  • Participate in the scientific publications (abstracts, posters, papers) for scientific meetings and in the creation of safety sections in the Study protocols, investigator’s brochures.
  • Contribute to the appropriate design of the clinical development plan throughout the development of the product.
  • Be a core member of the Project Team and the Drug Safety representative with other functions and departments as required.
Skills and competencies:
  • MD with at least 5 years of professional experience in clinical research in the pharmaceutical industry environment.
  • Previous experience in the development of monoclonal antibodies.
  • A background in immunology, paediatrics and/or rare disease would be an advantage.
  • Excellent communication skills.
  • Willing to be part of interdisciplinary teams with spirit of initiative and proactivity.
  • Excellence in written and spoken English.

Interested applicants should send their CV and motivation letter in English to hr-recruitment@novimmune.com. with a reference to the following job code in the subject line: DrugSafetyMD. For more information on Novimmune’s activities please refer to our website http://www.Novimmune.com