Switzerland
Posted 1 year ago
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
Job Features
Job Category | DRUG SAFETY |