Clinical Safety Scientist

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

Job summary

An innovative healthcare company is seeking a Clinical Safety Scientist for a fully remote contract role. This position focuses on providing safety support for HIV-related medicines, emphasizing signal detection and risk management. You will be responsible for authoring key regulatory documents and responding to audit requests. Ideal candidates will have a strong background in biomedical sciences and experience in medical writing and data analysis. Join a leading firm that invests significantly in research and development, contributing to groundbreaking healthcare solutions.

Qualifications

• Bachelor’s or higher degree in Biomedical or Healthcare-related specialties.
• Experience in scientific literature review and data analysis.

Responsibilities

• Provide safety support and expertise for HIV treatment and prevention.
• Author safety contributions to global regulatory submissions.

Skills

Medical Writing

Data Analysis

Signal Detection

Pharmacovigilance Regulations

Causality Assessment

Education

Bachelor's Degree in Biomedical Sciences

Master's Degree in Healthcare-related Field

Tools

Statistical Analysis Software

Regulatory Submission Platforms

Job description

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CK Group is recruiting for a Clinical Safety Scientist to join a company in the pharmaceutical industry on a contract basis for 6 months. This is a fully remote position.

Role:

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

This position is responsible for signal detection and evaluation activities for assigned products.

Further Responsibilities Include:

• Authoring the SERM safety contribution to global regulatory submissions in partnership with the product physician.
• Responding to auditors/inspectors’ requests for information/additional information and completing corrective and preventative actions (CAPAs) within agreed timelines.
• Driving the production of regulatory periodic reports, associated documentation, and RMPs globally.
• Assisting in authoring periodic regulatory documents (PSURs [PBRERs], DSURs, license renewal documentation) according to the agreed process and timelines.
• Updating investigator brochures.

Your Background:

• Bachelor’s or higher degree in Biomedical or Healthcare-related specialties.
• Experience in scientific literature review, data gathering, analysis, synthesis, and interpretation.
• Competent medical/scientific writing skills.
• Strong computing skills and knowledge of relevant pharmacovigilance regulations and methodologies applicable to SERM activities.
• Knowledge and experience of causality assessment principles and safety signal evaluation.

Company:

Our client is one of the largest global healthcare companies researching, developing, and supplying innovative medicines, vaccines, and healthcare products, headquartered in the UK. They invest around £1bn annually in research and development in the UK.