Clinical Safety Physician Oncology
vor 1 Tag
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.
For our Clinical Safety and Pharmacovigilance team in the Research and Development department based in Lausanne we are looking for a:
Clinical Safety Physician Oncology
In this role, you will be responsible for actively managing and evaluating risks associated with products in development in oncology, including 1 program in innovative products, under the responsibility of the Head of Clinical Safety and Pharmacovigilance.
**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 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 meeting 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
**Requirements**:
M.D. diploma with at least 6 years experience as Global Safety Physician, in early clinical phases of drug development in a pharmaceutical company (Biotech, big pharma, startup...)
First experience in oncology drug development would be preferable
First experience with Radiopharmaceuticals 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 team and facilitate communication and are able to make decisions
Able to work independently, to take responsibility for allocated projects/tasks, prioritize activities effectively and to 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
**Benefits**:
An international and highly dynamic environment, with a long term vision.
The opportunity to join a successful company, at the forefront of the most advanced scientific developments in the industry and be exposed to many areas within clinical development and the pharmaceutical industry.
The possibility to be in a company in which innovation, people and entrepreneurship are the fundamentals of its success.
Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external staffing agency or recruiter does not create any implied obligation on the part of Debiopharm.
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Lausanne, Schweiz Debiopharm VollzeitDescription 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...
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