Clinical Trials Director
2 weeks ago
We are seeking an expert in pharmacovigilance to lead a small team responsible for the processing and reporting of safety information on our clinical trials.
The successful candidate will oversee procedures for collection, processing, and reporting of serious adverse events, urgent safety measures, and other safety information from clinical trials sponsored by Cancer Research UK.
The ideal candidate will have significant experience in pharmacovigilance, working with safety databases, and electronic regulatory submissions.
Key Responsibilities:- Lead a small PV team to ensure timely submission and quality of development safety update reports (DSURs).
- System owner of the electronic safety database, working with the Technology department to ensure its proper selection, validation, maintenance, and use in accordance with SOPs and regulatory guidelines.
- Monitor and ensure compliance of regulatory reporting of safety information.
- Respond to audit and inspection findings, identifying and implementing corrective and preventive actions as appropriate.
- Degree in a scientific discipline or equivalent experience.
- Significant experience of working in pharmacovigilance.
- Experience in working with safety databases.
- Experience in electronic regulatory submissions.
- Ability to maintain rigorous adherence to written procedures, guidelines, and legal requirements.
Cancer Research UK is a world-leading charity dedicated to saving lives through research into cancer. We create a working environment that supports your wellbeing and provide a generous benefits package, a wide range of career and personal development opportunities, and high-quality tools.
We estimate the salary for this role to be around £70,000 - £90,000 per annum, depending on location and experience.
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