Safety Physician (Temporary 12 months) - Lausanne

☞ Debiopharm

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Update day: 26-03-2024

Location: Lausanne Vaud VD

Category: Health / Medical Care

Industry: Research Biotechnology Pharmaceuticals

Position: Associate

Job type: Temporary

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Job content

Description

Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and bacterial infections in order to improving patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to develop innovative therapies that target high unmet medical needs. Bridging the gap between disruptive discovery products and real-world patient reach, we identify high-potential compounds for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally.

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Debiopharm International S.A. identifies high-potential compounds for in-licensing, conducts clinical development and then selects large pharmaceutical commercialization partners to maximize patient access across the globe.

Safety Physician (Temporary 12 months)

In this role, you will be responsible for actively managing and evaluating risks associated with products in development in oncology and also antibiotics under the responsibility of the Head of Clinical Safety and Pharmacovigilance. You will also support deployment of the early phases in healthy volunteers in collaboration with the Clinical Pharmacology & Drug Metabolism team.

Your Main Responsibilities
  • Evaluate and establishes the safety profile of this product in collaboration with the different company experts and/or partner vendors
  • Provide medical input with respect to safety aspects of : the documents intended to be submitted in an accelerated approval procedure, preparation of investigator brochures, Development safety update reports
  • Be responsible for safety surveillance activities for this product including medical review of individual safety cases directly in the safety database and signal detection activities (ongoing review of safety data)
  • Ensure the oversight of medical activities outsourced to our PV vendor
  • Develop and lead, in collaboration with the relevant functions within clinical medicine, biometry and clinical pharmacology the implementation of a signal detection tool.
  • Be a member of study teams and work in a collaborative and proactive way in a matrix environment.
  • Participate in IDMC meeting or other safety related interactions with outside collaborators, and in internal safety task forces
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Deadline: 10-05-2024

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