Clinical Safety Scientist

JR United Kingdom; United Kingdom; Remote; GBP 40,000 - 80,000; Full time

Job summary

An established industry player is seeking a Clinical Safety Scientist to provide expertise in safety evaluation and risk management for HIV treatments. This fully remote role focuses on monitoring safety profiles throughout the product lifecycle, ensuring compliance with global regulatory standards. You will engage in pharmacovigilance activities, signal detection, and the authoring of critical regulatory documents. If you possess strong scientific writing skills and a background in biomedical fields, this is an exciting opportunity to contribute to vital healthcare advancements.

Qualifications

• Experience in scientific literature review and data analysis.
• Strong writing skills and knowledge of pharmacovigilance regulations.

Responsibilities

• Monitor and evaluate safety profiles for allocated products.
• Conduct pharmacovigilance activities and author regulatory documents.

Skills

Scientific writing

Data analysis

Pharmacovigilance regulations

Signal evaluation

Literature review

Education

Bachelor's degree in Biomedical or Healthcare-related fields

Job description

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Clinical Safety Scientist, United Kingdom

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

Job Description:

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.

Detailed responsibilities may include:

• 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.

Education, Knowledge, and Technical Experience:

• 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.