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- Tasks: Ensure safety compliance in clinical trials and serve as the primary medical contact.
- Company: Leading R&D team focused on innovative ophthalmic solutions.
- Benefits: Competitive salary, professional development, and a dynamic work environment.
- Why this job: Make a real impact in eye health while working with cutting-edge research.
- Qualifications: MD ophthalmologist with an active license and experience in safety reporting.
- Other info: Join a collaborative team with opportunities for growth in the medical field.
The predicted salary is between 36000 - 60000 £ per year.
As an Ophthalmologist within the clients R&D Clinicals team, you will work with 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.), while serving as the primary medical contact for internal and external investigators.
As the Ophthalmologist you will be responsible for ensuring safety compliance and serving as the primary medical contact for clinical trial activities.
Responsibilities- 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.
- 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.
- Participate in or facilitate 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.
- MD ophthalmologist with active license.
- Experience with 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.
- Ideally 7-10 years of experience with pharmacovigilance, regulatory affairs or medical monitoring.
- Experience in contact lens or medical device industry preferred.
Ophthalmologist in England employer: Lenntech Search
Contact Detail:
Lenntech Search Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Ophthalmologist in England
✨Tip Number 1
Network like a pro! Reach out to your contacts in the ophthalmology field, attend relevant conferences, and join online forums. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ICH-GCP and regulatory requirements. Be ready to discuss how your experience aligns with safety compliance and clinical trial activities. We want to see that you can talk the talk!
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and career goals. Use our website to find roles that excite you and tailor your approach to each one. It’s all about finding the right fit!
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way in showing your enthusiasm for the role. Plus, it keeps you fresh in their minds as they make their decision.
We think you need these skills to ace Ophthalmologist in England
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to highlight your experience in ophthalmology and clinical trials. We want to see how your background aligns with the responsibilities listed in the job description, so don’t hold back on showcasing relevant skills!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about this role and how your experience makes you the perfect fit. We love seeing genuine enthusiasm, so let your personality come through.
Highlight Relevant Experience: When detailing your work history, focus on experiences that relate directly to safety compliance, regulatory requirements, and clinical trial activities. We’re looking for specific examples that demonstrate your expertise in these areas.
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates from our team!
How to prepare for a job interview at Lenntech Search
✨Know Your Regulations
Familiarise yourself with the key regulations like ICH-GCP, FDA, and EU-MDR. Being able to discuss these in detail will show that you understand the compliance landscape and can navigate it effectively.
✨Prepare for Clinical Scenarios
Think about potential clinical trial scenarios you might face as an Ophthalmologist. Be ready to discuss how you would handle adverse events or safety compliance issues, showcasing your problem-solving skills.
✨Showcase Your Communication Skills
Since you'll be the primary medical contact, practice articulating complex medical concepts clearly. Use examples from your past experiences where effective communication made a difference in a clinical setting.
✨Highlight Your Experience
Be prepared to discuss your background in pharmacovigilance or medical monitoring. Share specific examples of projects you've managed, especially those involving safety reporting or regulatory affairs, to demonstrate your expertise.