P2271 - Safety Scientist
vor 23 Stunden
Description
Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and infectious diseases in order to improve 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. Our unique “development only” business model allows us to act as a bridge between disruptive discovery products and patient access in international markets. We first 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.
At Debiopharm you will be at the forefront of the fight against cancer and infectious diseases, and you will have the opportunity to work on new innovative medicines for patients. Efficiency is our mode of action, saving lives our collective target.
For our Clinical Safety and Pharmacovigilance organization based at our Headquarters in Lausanne, we are looking for a
Safety Scientist
Reporting to the Head of Clinical Safety and Pharmacovigilance, the Safety Scientist supports safety physicians with: data review, signal management and risk assessment activities to assess the Debiopharm product portfolio safety profile. The Safety Scientist will assess Debiopharm product portfolio, under clinical development, in collaboration with the Clinical Medicine, Biometry, Translational Medicine and Clinical Operations departments.
Your responsibilities will be but not limited to:
Conducts Signal Management activities including Signal Detection and Evaluation of safety data collected in clinical trials, literature, and other safety relevant data under the responsibility of Safety Physicians. And in collaboration with departments of clinical medicine, biometry, translational medicine, and clinical operations.
Ensures the appropriate documentation of these signal detection activities including the production of reports and minutes of Safety Assessment Committees.
Reviews standard design of tables, figures, and listings from clinical studies safety data.
Participates in the development of safety-related data collection forms (i.e. AE form design in EDC) for clinical studies.
Contributes to the development and maintenance of SOPs on signal management activities and implementation of Signal Detection Tools in close collaboration with safety physicians.
Be the referent person for the signal detection tool which will be implemented.
Generates reports from the signal detection tool and the safety database and for the analysis of safety-related data in a multidisciplinary setting including Clinical Medicine, Translational Medicine, Data Management and Biostatistics to understand the safety profiles of drugs under development within the context of periodic or adhoc safety risk evaluations.
Provides input into clinical trials documents including protocols, Investigator Brochures, Development Safety Update Reports for assigned investigational programs together with Clinical Safety Officers and Safety Physicians.
Contributes to risk management activities, including preparation of safety aspects for development risk management plans and risk mitigation strategies.
Contributes to the preparation of responses to safety questions from regulatory authorities.
Reviews the signal analysis strategy as described in the adhoc section of the Safety management Plan.
Supports clinical safety medical activities as needed.
**Requirements**:
Master’s in Science, PhD in Science, Pharmacist (Medical Biotechnology, Pharmacy..).
More than 5 years of experience in Clinical Safety and Pharmacovigilance with good knowledge of GCP and GVP as well as EU and US regulations.
Experience in Oncology and/or anti-infective diseases.
Solid experience in drug development and clinical research at different phases (mainly I-III)
Strong analytical and organizational skills, as well as familiarity with medical terminology.
Good understanding of data analysis, statistical methods to evaluate, interpret and present clinical safety data.
Good written and verbal communication skills and ability to interact with a wide range of people.
Team-player, flexible and willing to support and work with employees at all levels in the organization and across all functions.
Ability to face challenges and solve problems and pro-active.
Dynamic, positive can-do attitude.
Fluent in English, French is an asset.
**Benefits**:
Debiopharm offers employees:
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, pe
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