Clinical Safety Scientist

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Clinical Safety Scientist – HIV Medicines

Join our team to provide safety expertise with a focus on medicines used for the treatment and prevention of HIV. You'll be responsible for evaluating safety profiles and supporting risk management throughout the product lifecycle, from late-stage development to post-marketing use.

Role Responsibilities

• Monitor and evaluate safety profiles for assigned products
• Support regulatory decision-making by conducting routine pharmacovigilance activities
• Contribute to signal detection and evaluation processes
• Author key regulatory documents such as DSURs, EU RMPs, and PBRERs
• Produce and update global Risk Management Plans
• Assist with the update of investigator brochures
• Contribute to regulatory benefit-risk assessments
• Conduct literature reviews and use signal detection tools (e.g. CommonWealth Vigilance Workbench)
• Prepare accurate evaluation documents with clear conclusions
• Assist in preparing periodic regulatory submissions including PSURs/PBRERs, DSURs, and licence renewals

Role Requirements

• Bachelor’s degree (or higher) in a biomedical or healthcare-related field
• Experience in scientific literature review, data analysis, and interpretation
• Strong written communication skills in medical/scientific contexts
• Familiarity with pharmacovigilance regulations and SERM methodologies
• Understanding of causality assessment and safety signal evaluation
• Basic knowledge of HIV therapy area (desirable)