Associate Signal Assessor

Associate Signal Assessor

We are currently looking for an Associate Signal Assessor to join our Patient Safety Monitoring Function within the Safety & Surveillance group.

This is a full time opportunity, on a permanent basis. The role will be based in 10 South Colonnade, Canary Wharf London, E14 4PU.

The Medicines and Healthcare products Regulatory Agency enhances and improves the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research.

The new Safety and Surveillance Group brings together a cohesive team of devices and medicines safety expertise. The dual functions of our data and evidence sourcing complementing our signal generation capabilities allows the Group to have patient safety as the main priority.

The Patient Safety Monitoring Function is responsible for developing and delivering a world class vigilance system to detect and monitor safety signals for medicines, medical devices, vaccines and blood products.

What's the role?

The Adverse Incident & Signal Analysis team is responsible for the capture of adverse incidents for medicines and devices. Vigilance signal detection and assessment processes are undertaken for medicines and devices to ensure safety issues and risks to public health are identified and evaluated. Additional activities for this role include responding to enquiries from stakeholders and provision of adverse incident data to stakeholders and project specific work. The successful applicant will work flexibly across the range of healthcare products.

Key Responsibilities

• Classification and follow up of adverse incident reports to ensure the accuracy, quality and timely production of vigilance incident cases.
• Vigilance signal detection and evaluation and attendance at review meetings.
• Provide clear, reliable and timely scientific, regulatory advice and data for FOI requests and all types of queries.
• Involved in vigilance additional role work and projects including NHS data review, liaison with our Yellow Card Centres, improvement of electronic incident submission with website and app maintenance and enhancements, vigilance terminology maintenance and engagement with manufacturers.

Who are we looking for?

• Able to work on own initiative and work effectively as part of a team, demonstrating good organisational skills.
• Excellent written and verbal communication skills.
• Proven ability to produce work to high standards of quality within a pressured time frame.
• Ability to analyse and interpret complex data and make appropriate recommendations under pressure, putting forward own viewpoints when discussing scientific issues.
• A University degree or equivalent qualification in disciplines such as pharmacy, medicine, nursing, physiology, pharmacology, toxicology, biological sciences, engineering or other appropriate life science.