Debiopharm seeks a Senior Safety Physician for its Clinical Safety and Pharmacovigilance team in Lausanne. The role focuses on managing product risks in oncology and antibiotics while supporting early-phase clinical trials.
This position sits within the Clinical Safety and Pharmacovigilance team in the Research and Development department in Lausanne. The physician will manage and assess risks for oncology and antibiotic products in development. The role also supports early-phase studies in healthy volunteers alongside the Clinical Pharmacology & Drug Metabolism team.
Responsibilities
- Assess and define the safety profile of products alongside internal experts and external partners.
- Offer medical guidance on safety matters for documents supporting accelerated approval, investigator brochures, and development safety update reports.
- Oversee safety surveillance, including medical review of individual safety cases in the database and signal detection.
- Supervise medical activities outsourced to the pharmacovigilance vendor.
- Lead the implementation of a signal detection tool with clinical medicine, biometry, and clinical pharmacology teams.
- Serve on study teams and collaborate effectively in a matrix environment.
- Attend IDMC meetings and engage in safety-related discussions with external collaborators and internal task forces.
Requirements
- Proven experience in clinical safety during early drug development phases within a global pharmaceutical or CRO setting.
- Minimum of five years of direct experience in clinical safety within the biotech or pharmaceutical industry.
- Strong leadership, management, collaboration, communication, and decision-making abilities.
- Ability to prioritize tasks, meet multiple deadlines, and maintain attention to detail.
- Excellent written and verbal communication skills in English.
Nice to have
- Prior experience in oncology drug development, particularly in early stages.
- French language proficiency.
- Proficiency with the Microsoft 365 suite and an interest in digital tools.
What the company offers
- An international, dynamic work environment with a long-term strategic vision.
- Cross-functional collaboration at the forefront of advanced scientific developments in oncology and anti-bacterial fields.
- Exposure to diverse areas and functions within clinical development and the pharmaceutical industry.
- Opportunity to join a company where innovation, people, and entrepreneurship drive success.
- Equal-Pay certification ensuring equal opportunities for all employees.
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