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Drug Safety Physician

CTC Resourcing Solutions

Basel area
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Our client is a biotech company that has an exciting pipeline and a product that has recently received FDA Approval. With a focus on developing clinically challenging products within Oncology and Immune related diseases. A dynamic and innovative company, they are now looking to expand and are actively recruiting for a Drug Safety Physician for a permanent position to be based in the Basel area.

The ideal candidate should have 5+ years of previous experience in Clinical safety in the pharmaceutical or biotechnology industry.

Drug Safety Physician

Main Responsibilities:

  • Accountable for all aspects of safety related to the assigned projects/products including medical assessment, aggregate reporting, signal detection, risk management, and risk minimization activities throughout the product’s life cycle;
  • Take care of all aspects of safety related to products in development, including single case assessment, aggregate reporting, signal detection, risk management throughout the life cycle;
  • Establish safety analyses including medical evaluation, risk management, signal detection using epidemiology and other input as appropriate in order to ensure that adequate measures based on safety findings are taken;
  • Support the Clinical team in bringing the safety expertise in interaction with Heath Authorities, Data Monitoring Committees and Investigators;
  • Create safety sections in the study protocols, Investigator’s Brochures and all required safety 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.


Qualifications and Experience:

  • Doctor of Medicine degree with at least 5+ years experience in clinical safety in the pharmaceutical or biotechnology industry;
  • The product is for Rare Diseases therefore is clinically very challenging and experience in a clinically complex area as Immunology/ Autoimmune diseases and/or Oncology, Haematology would be an advantage;
  • Excellent medical writing, presentation and communication skills;
  • Good experience and knowledge with safety signal identification methodology and risk minimization measures;
  • Knowledge of global safety regulations, Good Clinical Practice (GCP) and Pharmacovigilance compliance requirements;
  • Willing to be part of interdisciplinary teams with spirit of initiative and proactivity;
  • Excellence in written and spoken English;
  • Relevant working/residency permit or Swiss/EU-Citizenship required.


CTC Clinical Trial Consulting AG
Mr CTC Resourcing Solutions
Münchensteinerstrasse 41
4052 Basel
+41 61 695 88 66


Website http://www.ctcresourcing.com

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