Medical Monitor / Medical Vigilance Officer / Medical Safety Officer in Eastleigh

Job title: Medical Monitor / Medical Vigilance Officer / Medical Safety Officer

Department: R&D Clinicals

Location: Southampton, Hampshire, UK

GLS: T04

Working hours: 37.5 hours per week Monday to Friday

A brighter future awaits you

Job Summary

The Medical Monitor / Medical Vigilance Officer / Medical Safety Officer will provide expert ophthalmic assessment of adverse events, support regulatory compliance for UK/EU/global vigilance obligations and enhance both pre‑market & post‑market clinical evidence by contributing clinical insight into complaint trends, safety signals, and product investigations. Ultimately, ensuring the safety and integrity of clinical trials and global regulatory safety compliance.

Your responsibilities will include:

• Serve as Medical Monitor for pre‑market and post‑market clinical trial activities to ensure safety compliance with protocols, ICH‑GCP, and regulatory requirements (e.g. FDA, EU‑MDR, ISO etc.).
• Review adverse event (AE) submissions for completeness, clarity, and appropriateness of severity and relatedness classification in a timely fashion to ensure compliance with reporting timelines.
• Serve as the primary medical contact for internal and external investigators and supporting personnel.
• Report Serious Adverse Events (SAEs) and Unanticipated Serious Adverse Device Effects (USADEs) to Regulatory Affairs (RA) and the relevant notified bodies, as required, and within required timeframes.
• Perform monthly review of pre‑market AEs with RA.
• Generate monthly KPI reports for distribution to RA and Quality Assurance (QA) functions for pre‑market studies.
• Contribute to benefit–risk assessments and documentation for product investigations and CAPA activities (as needed).
• Support clinical assessments for risk management files and technical documentation.
• Work with RA and QA to review global complaints, AEs and failure rates.
• Serve as SME for protocol, investigator brochure, study reports, etc. relative to safety endpoints.
• Provide safety input into Product Hazard assessments and evaluations.
• Support R&D QA during audits for inquiries relating to AE and Product Complaint reporting.
• Participating in or facilitating Data Safety Monitoring Board (DSMB) reviews.
• Develop and oversee delivery of safety training materials.
• Collaborate with RA on review and assessment of documents of external origin (DOEO) and relevance to ongoing clinical activities.

Knowledge, Skills and Experience:

• Experience with medical device vigilance, safety reporting and/or Health Hazard Evaluations.
• Understand standardized medical coding, GCP, ISO and regulatory reporting requirements.
• Ability to manage multiple projects and adjust to changing priorities.
• Excellent communication skills, both verbal and written, including appropriate use of medical and scientific terminology.
• Optometry or ophthalmology background/training.

Experience/Education:

• Licensed UK Ophthalmologist (GMC registered). At least 3 years of experience with pharmacovigilance, regulatory affairs or medical monitoring.
• Experience in contact lens or medical device industry preferred.

What we offer:

You’ll receive competitive compensation and a fantastic benefits package including bonus, private medical insurance, 25 days holiday, pension scheme, healthcare cover, life assurance, access to our Wellness Platform to support you in mental health and wellbeing, a discounted contact lens scheme and much more!

All suitably qualified applicants will receive equal consideration and opportunities from CooperVision.