Clinical Safety Scientist

2 days ago

London, Greater London, United Kingdom SRG Full time £59,400 per year

Job Title: Clinical Safety Scientist

Contract:
12 months

Pay Rate:
£495 per day (umbrella)

Location:
Fully Remote

About the Role

We are seeking a
Clinical
Safety Scientist
to provide expert safety support with a particular focus on medicines for the treatment and prevention of HIV. This role is critical in ensuring robust safety evaluation and risk management throughout the product lifecycle—from late-phase clinical development to established post-marketing use.

You will be responsible for monitoring and evaluating safety profiles for allocated products, conducting routine pharmacovigilance activities, signal detection and evaluation, and authoring key regulatory documents such as DSURs, EU RMPs, and PBRERs. Accuracy and compliance with global regulatory requirements are essential.

Key Responsibilities

  • Author or assist in producing global Risk Management Plans for designated products.
  • Contribute to regulatory benefit-risk assessments.
  • Update investigator brochures as required.
  • Support routine signal detection processes (experience with Commonwealth Vigilance Workbench advantageous), literature reviews, and case awareness tools.
  • Perform signal evaluation activities, including safety data analysis and preparation of clear, fit-for-purpose evaluation documents.
  • Assist in authoring periodic regulatory documents (PSURs/PBRERs, DSURs, licence renewal documentation) within agreed timelines.

Education, Knowledge & Experience

  • Bachelor's degree or higher in Biomedical or Health Care-related discipline.
  • Experience in scientific literature review, data gathering, synthesis, and interpretation.
  • Strong medical/scientific writing skills.
  • Sound computing skills and knowledge of pharmacovigilance regulations and methodologies.
  • Understanding of causality assessment and safety signal evaluation principles.
  • Basic knowledge of HIV therapy area (advantageous).
  • Familiarity with related disciplines (statistics, pharmacoepidemiology), medical/drug terminology, drug development, and approval processes.

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