Safety Physician, Oncology Early Phases

☞ Debiopharm

View: 156

Update day: 26-03-2024

Location: Lausanne Vaud VD

Category: Health / Medical Care

Industry: Research Biotechnology Pharmaceuticals

Position: Associate

Job type: Full-time

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Job content

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.
Here: https://apply.workable.com/debiopharm-group-sa/
Debiopharm International S.A. identifies high-potential compounds for in-licensing, conducts clinical development and then selects large pharmaceutical commercialization partners to maximize patient access across the globe.

For Our Clinical Safety And Pharmacovigilance Team In The Research And Development Department Based In Lausanne We Are Looking For a

Safety Physician, Oncology Early Phases(100%)
In this role, you will be responsible for actively managing and evaluating risks associated with products in development, mostly in Early Phases in oncology innovative products such as Radiopharmaceutical products.This role reports to 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 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
Requirements
  • 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
  • Experience in hepatic and cardiac safety management,
  • First experience drug development within Oncology
  • 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
  • Must possess computer skills by using MS Word, Excel, and Microsoft Outlook
  • Ability to function effectively in high-stress situations
  • Demonstrate excellent written and verbal communication skills in English and French
  • Strong Team-Spirit and looking to work within cross-functional 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.
The use of external staffing agencies or recruiters requires prior approval from our Human Resources Department. The Human Resources Department at Debiopharm requests that 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
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Deadline: 10-05-2024

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