Clinical Safety Scientist

☞ PharmiWeb.Jobs

Ver: 186

Dia de atualização: 24-04-2024

Localização: Basel Basel-Stadt BS

Categoria: R & D IT - Software

Indústria: Research Services Biotechnology Research Pharmaceutical Manufacturing

Posição: Associate

Tipo de empregos: Contract

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Conteúdo do emprego

A current vacancy as a Clinical Safety Scientist with a leading pharmaceutical company is available in Switzerland.

Our client is looking for candidates based in Switzerland / EU passport holders for a 6-month, full time contract.

The ideal candidate must have a minimum of 5 to 7 years of relevant experience in Safety (DSR, CSR, IB, DSUR, etc.), with a Life Science education background.

Responsibilities Include
  • Develop and maintain an expert understanding of the safety profile and relevant strategic context (e.g., disease under study, safety profile of competitors, mechanism of action)
  • Responsible for signal detection and management activities
  • Contribute to the review of safety assessments and drug safety reports for signals or issues (inc, product quality) or in response to Regulatory Authority requests
  • Provide expert contribution to the development of the product safety strategy
  • Review of clinical protocols, study reports, Investigator’s Brochure (IB), informed consent form (ICF) and other related documents to ensure alignment with the safety strategy
Requirements:
  • Education in Life Sciences
  • Minimum 5 to 7 years of relevant hands on experience in Safety/Pharmacovigilance
  • Hands on experience with clinical trial and mature products safety
  • Hands on working experience with Risk Management Plan, Protocols, DSR, DSUR, CSR, IB, Adverse Events, etc.
  • Demonstrated ability to lead and influence, with and without authority, in a global matrix environment.
  • Apply complex data analysis / statistical methods to evaluate, interpret and present scientific data with clarity
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Data limite: 08-06-2024

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