Clinical Safety Physician, Early Drug Development

Key responsibilities

• Evaluate and establish the safety profile of this product in collaboration with the different company experts and/or partner vendors
• Provide expert safety input to the clinical development program, study documents such as study protocols, informed consent, investigator brochures, Development Safety Update Report
• 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)
• Escalates and presents safety issues at company safety governance bodies
• Ensure the oversight of medical activities outsourced to our PV vendor
• Be a member of study teams and work in a collaborative and proactive way in a matrix environment.
• Participate in IDMC meetings or other safety-related interactions with outside collaborators, and in internal safety task forces
• Be involved in process optimization initiatives and, where needed, set up new activities

Your profile

• M.D. diploma with at least 4 years experience as a Safety Physician in clinical safety in early clinical phases of drug development in a global pharmaceutical or global CRO
• Firsthand experience in oncology drug development is a plus
• Strong experience and knowledge of international clinical development regulations applicable to drugs
• Experience with Safety Database
• Experience and willingness to analyze and manage significant safety issues in clinical development
• Ability, as a leader, to collaborate with cross-functional teams and facilitate communication and are able to make decisions
• Able to work independently, to take responsibility for allocated projects/tasks, prioritize activities effectively, and meet multiple deadlines successfully with attention to detail, setting high-performance standards for quality
• Ability to function effectively in high-stress situations
• Demonstrate excellent written and verbal communication skills in English
• Proficient in MS Office (Excel, Word, PowerPoint, Outlook, Teams