Flame Health Optometry have been instructed to work with a confidential vision-care organisation on the appointment of a Medical Monitor/Medical Safety/Medical Vigilance Officer in Hampshire, with a salary of £90,000 to £120,000 plus a 10% bonus. This role will suit an ophthalmology or optometry professional with independent prescribing who combines clinical judgement with strong regulatory awareness and wants to support both pre-market and post-market programmes.
This position sits within R&D Clinicals and reports to the Director, Post Market Clinical Affairs. The Medical Monitor will oversee clinical trial safety activities, review adverse event submissions for accuracy and completeness, and ensure reporting is handled within the required timeframes and in line with ICH-GCP, FDA, EU-MDR and ISO requirements.
The role includes acting as the primary medical contact for internal and external investigators, escalating Serious Adverse Events and Unanticipated Serious Adverse Device Effects to Regulatory Affairs and the relevant notified bodies, and working with RA and QA on global complaints, adverse events and failure rates.
The postholder will also contribute safety input to protocol documents, investigator brochures, study reports and product hazard assessments, support audits, participate in Data Safety Monitoring Board reviews, develop safety training materials, and review documents of external origin for relevance to ongoing clinical activity.
Our client is a confidential organisation operating in the vision-care medical device sector, with a focus on R&D and clinical safety oversight. The role is based within a clinical affairs function and offers limited travel, with support available for visa sponsorship and relocation for the right candidate. It is a hands-on position in a normal office environment, with prolonged computer-based work and close collaboration across Regulatory Affairs, Quality Assurance and wider clinical stakeholders.
A qualified ophthalmologist with an active licence, or an optometrist with IP, is required. The successful candidate will bring experience in safety reporting or health hazard evaluations, together with a strong understanding of standard medical coding, GCP, ISO and regulatory reporting requirements.
Ideally, you will have seven to ten years’ experience in pharmacovigilance, regulatory affairs or medical monitoring, and experience within the contact lens or wider medical device sector would be preferred. Excellent written and verbal communication skills are essential, including accurate use of medical and scientific terminology, alongside the ability to manage multiple projects and respond effectively to changing priorities.
This role will appeal to an experienced clinical professional who wants to move or progress into a medical monitoring position with real influence over study safety and regulatory compliance. It will suit someone who enjoys cross-functional working, clear accountability and the opportunity to apply ophthalmic expertise in a highly regulated environment.
The position is based onsite in Hampshire, on the South Coast. It is within reach of the wider Portsmouth and Southampton area; relocation support is available for the right candidate.
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