P2620 - Safety Physician Oncology

For our Clinical Safety and Pharmacovigilance team in the Research and Development department based in Lausanne we are looking for a:

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 responsibilities will be but not limited to:

• 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

Your profile

·         M.D., with experience in clinical safety in early clinical phases of drug development in a global pharmaceutical or global CRO

·         At least 5 years of direct experience in Biotech/Pharmaceutical industry in clinical safety

·         First experience in oncology drug development, in early stages an asset

·         Excellent leadership, management, collaboration, communication and decision making skills

·         Able to prioritize activities effectively and to meet multiple deadlines successfully with attention to detail, setting high performance standards for quality

·         Master Microsoft 365 suite, appetite for digital tools a plus

·         Demonstrate excellent written and verbal communication skills in English, French an asset