Safety jobs in Großbritannien

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Client: LanceSoft, Inc.

Location: United Kingdom

Job Category: Other

EU work permit required: Yes

Job Views: 4

Posted: 26.04.2025

Expiry Date: 10.06.2025

Fully Remote

Duration: 6 Months

Safety Scientist:

To provide safety support and expertise with particular focus on medicines for the treatment and prevention of HIV. The key focus is on safety, evaluation, and risk management.

Day-to-day responsibilities include monitoring and evaluating safety profiles for allocated products to ensure optimal decisions throughout the product lifecycle, from late-phase clinical development to post-marketing use. Responsibilities may include conducting pharmacovigilance activities, signal detection/evaluation, and authoring regulatory documents such as DSURs, EU RMPs, and PBRERs. Ensuring safety documentation meets global compliance and regulatory standards is essential.

• Authors or assists in the production of global Risk Management Plans for designated products, in consultation with senior colleagues.
• Contributing to regulatory benefit-risk assessments.
• Assisting in the update of investigator brochures.
• Supporting routine signal detection, literature review, and safety data analysis, in collaboration with safety physicians.
• Performing signal evaluation activities, analyzing safety data, and producing evaluation documents with clear conclusions.
• Assisting in authoring periodic regulatory documents (PSURs, PBRERs, DSURs) according to timelines.

• Bachelor's or higher degree in Biomedical or Healthcare-related fields.
• Experience in scientific literature review, data gathering, analysis, and interpretation.
• Strong scientific writing skills.
• Knowledge of pharmacovigilance regulations and methodologies.
• Understanding of causality assessment and safety signal evaluation.
• Basic understanding of HIV therapy area is advantageous.
• Knowledge of disciplines like statistics and pharmacoepidemiology.
• Familiarity with medical and drug terminology.
• Understanding of the drug development and approval processes.