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Drug Safety Physician

Posted on Oct 24, 2019 by Helvetica Partners Sarl

Basel, Switzerland
Health Care
Immediate Start
Annual Salary
Full-Time

For one of our clients, a drug discovery and development company located in Switzerland, that focuses on developing therapeutic monoclonal antibodies for inflammatory diseases and immune-related disorders.

We are looking for a Drug Safety Physician to manage safety information and medical reviews in clinical trials.

Key responsabilities

The Drug Safety Physician will be accountable for all aspects of safety related to products in development, including individual case assessment, aggregate reporting, signal detection, risk management throughout the life cycle

Responsible for overall signal detection, monitoring, evaluation, interpretation and appropriate management of safety information

Support the Clinical team in bringing the safety expertise in interaction with Heath Authorities, Data Monitoring Committees and Investigators

Review, contribute and provide medical and safety expertise for investigator brochures, protocols, informed consent, CRFs, clinical study reports, briefing books and other safety related documents

Contribute to the design of the clinical development plan throughout the development of the product

Be a core member of the Project Team and the Drug Safety representative with other functions and departments as required

Skills and competencies

Doctor of Medicine degree is required

At least 5 years of experience in the drug safety environment of pharmaceutical or biotechnology industry with expertise in all phases of drug development are required

Solid scientific background and clinical development knowledge, experience and ability to interpret clinical study safety information is required

Knowledge of international safety regulations (primarily ICH-GCP, EU and FDA regulations) is required

A background in Immunology/Autoimmune diseases and/or Oncology would be an advantage

Excellent communication, organizational, problem-solving, and interpersonal skills and theability to meet timelines

Is willing to be part of interdisciplinary teams, to work collaboratively with spirit of initiative and proactivity

Fluency in English is required

Travel requirements ~15%

Reference: 781462827

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