CooperVision
Medical Monitor / Medical Vigilance Officer / Medical Safety Officer
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Job Description
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
CooperVision, a global leader in soft contact lenses, is seeking a licensed UK Ophthalmologist to support clinical safety evaluation, post-market vigilance, and device risk management for its diverse contact lens portfolio.
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.
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A Full Job Description Is Available Upon Request.
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.
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Experience/Education:
- Licensed UK Ophthalmologist (GMC-registered), or Optometrist with UK Independent Prescribing qualification.
- 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:
- Competitive compensation.
- 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!
- Commitment to employees’ personal and professional development.
- Extensive training to support career growth.
- Access to LinkedIn Learning to help you develop in your career and grow with CooperVision.
What you can expect:
- A diverse and progressive global business.
- Opportunities for employees to learn and grow within an inclusive and safe space.
- CooperPride, African Descent, Woman’s Impact Network and Mind Body and Wellbeing Employee Resource Groups.
If you like what you see, take the first step towards your Brighter Future and apply today! All suitably qualified applicants will receive equal consideration and opportunities from CooperVision.
Please view our careers page at https://hcjy.fa.us2.oraclecloud.com/hcmUI/CandidateExperience/en/sites/CX_1 to view all other opportunities.
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