Clinical Safety Scientist
Location: London/Hybrid
Sector: Pharmaceutical / Drug Safety / Pharmacovigilance
CY Partners are recruiting for a Safety Scientist to join a leading pharmaceutical organisation focused on the development and delivery of innovative medicines for the treatment and prevention of HIV.
This is an excellent opportunity for a scientifically minded professional with pharmacovigilance experience to play a key role in safety evaluation, risk management, and regulatory compliance throughout the product lifecycle. Working within a collaborative safety team, you will contribute to ensuring the continued benefit-risk profile of medicines from late-stage clinical development through to post-marketing use.
The Role
As a Safety Scientist, you will be responsible for the ongoing monitoring and evaluation of safety profiles for assigned products, supporting optimal decision-making across all stages of development and commercialisation. You will contribute to routine pharmacovigilance activities, signal detection and evaluation, and the preparation of key regulatory safety documents, ensuring compliance with global regulatory requirements.
Key Responsibilities
- Support the monitoring, assessment and communication of product safety information.
- Author or contribute to global Risk Management Plans (RMPs) for designated products.
- Assist with regulatory benefit-risk assessments and safety evaluations.
- Contribute to the maintenance and updating of Investigator Brochures.
- Participate in routine signal detection activities, literature reviews, and case awareness processes.
- Conduct signal evaluation activities, including analysis and interpretation of safety data, and prepare clear, evidence-based evaluation reports.
- Support the preparation of periodic regulatory safety documents including:
- Periodic Benefit-Risk Evaluation Reports (PBRERs)
- Development Safety Update Reports (DSURs)
- Licence renewal documentation
- Ensure all safety documentation is accurate, compliant, and delivered within agreed timelines.
- Collaborate closely with Safety Physicians and cross-functional teams to support global pharmacovigilance activities.
Requirements
Essential
- Bachelor's degree or higher in Biomedical Sciences, Life Sciences, Pharmacy, Healthcare, or a related discipline.
- Experience in scientific literature review, data collection, analysis, interpretation, and synthesis.
- Strong medical and scientific writing skills.
- Knowledge of pharmacovigilance regulations and methodologies.
- Understanding of causality assessment principles and safety signal evaluation.
- Strong IT and data management skills.
- Knowledge of medical and pharmaceutical terminology.
- Basic understanding of the drug development and regulatory approval processes.
Desirable
- Previous experience within drug safety, pharmacovigilance, or pharmaceutical development.
- Familiarity with signal detection tools, including CommonWell/CVW Vigilance Workbench.
- Understanding of HIV therapeutics and infectious disease drug development.
- Knowledge of related disciplines such as pharmacoepidemiology or biostatistics.
What's on Offer?
- Opportunity to contribute to medicines that have a significant impact on global public health.
- Exposure to both clinical development and post-marketing pharmacovigilance activities.
- Collaborative and supportive working environment.
- Professional development within a highly regarded drug safety function.
For more information or to discuss this opportunity confidentially, please contact CY Partners today.
CY Partners is acting as an Employment Agency in relation to this vacancy.