For our
Clinical Safety and Pharmacovigilance
team in the
Research and Development
department based in Lausanne we are looking for a:
Safety Physician Oncology 100%, Permanent contract, in Lausanne HQ.
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
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
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
Benefits
International, highly dynamic environment with a long-term vision.
Cross-functional collaboration at the forefront of the most advanced scientific developments in oncology and anti-bacterial industry
Exposure to a wide variety of areas and functions within clinical development and the pharmaceutical industry
Participation in a company where innovation, people and entrepreneurship are the fundamental keys to success.
Proud to be an Equal-Pay certified, we ensure offering to all our employees the same opportunities
The use of external staffing agencies or recruiters requires prior approval from our Human Resources Department. The Human Resources Department at Debiopharm requests external staffing agencies or recruiters not to contact Debiopharm employees or members of the Board of Directors directly in an attempt to present candidates.
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.
Debiopharm will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions.
#J-18808-Ljbffr
Clinical Safety and Pharmacovigilance
team in the
Research and Development
department based in Lausanne we are looking for a:
Safety Physician Oncology 100%, Permanent contract, in Lausanne HQ.
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
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
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
Benefits
International, highly dynamic environment with a long-term vision.
Cross-functional collaboration at the forefront of the most advanced scientific developments in oncology and anti-bacterial industry
Exposure to a wide variety of areas and functions within clinical development and the pharmaceutical industry
Participation in a company where innovation, people and entrepreneurship are the fundamental keys to success.
Proud to be an Equal-Pay certified, we ensure offering to all our employees the same opportunities
The use of external staffing agencies or recruiters requires prior approval from our Human Resources Department. The Human Resources Department at Debiopharm requests external staffing agencies or recruiters not to contact Debiopharm employees or members of the Board of Directors directly in an attempt to present candidates.
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.
Debiopharm will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions.
#J-18808-Ljbffr
P2620 - Safety Physician Oncology Arbeitgeber: Debiopharm
Unser Unternehmen ist ein hervorragender Arbeitgeber, der Innovation und Zusammenarbeit in den Mittelpunkt seiner täglichen Arbeit stellt. Mit einem inklusiven und respektvollen Arbeitsumfeld, das stolz auf die Equal-Pay-Zertifizierung ist, bieten wir unseren Mitarbeitern die Möglichkeit, in einer Kultur zu wachsen, die Menschen, Zweck und Leistung schätzt. Hier haben Sie die Chance, die Zukunft des Gesundheitswesens aktiv mitzugestalten und sich in einem dynamischen Team weiterzuentwickeln.
