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- Tasks: Ensure safety compliance in clinical trials and serve as the primary medical contact.
- Company: Leading R&D team in the ophthalmology field with a focus on innovation.
- Benefits: Competitive salary, professional development, and opportunities for impactful work.
- Why this job: Make a difference in patient safety and contribute to groundbreaking research.
- Qualifications: MD ophthalmologist with an active license and experience in safety reporting.
- Other info: Dynamic role with opportunities for growth in a collaborative environment.
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 Portsmouth employer: Lenntech Search
Contact Detail:
Lenntech Search Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Ophthalmologist in Portsmouth
✨Tip Number 1
Network like a pro! Reach out to your contacts in the ophthalmology field and let them know you're on the lookout for opportunities. You never know who might have a lead 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, as this will show you're the right fit for the role.
✨Tip Number 3
Don’t just apply anywhere; focus on companies that excite you! Use our website to find roles that match your skills and interests. Tailor your approach to each company to stand out from the crowd.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way in keeping you top of mind. Mention something specific from your conversation to remind them why you’re the perfect candidate.
We think you need these skills to ace Ophthalmologist in Portsmouth
Some tips for your application 🫡
Read the Job Description Thoroughly: Before you start your application, make sure to read the job description carefully. It’s crucial to understand what we’re looking for in an Ophthalmologist so you can tailor your application accordingly.
Showcase Your Relevant Experience: When writing your application, highlight your experience with safety reporting and clinical trials. We want to see how your background aligns with our needs, so don’t hold back on those details!
Use Clear and Professional Language: Since communication is key in this role, ensure your application is well-written and free of jargon. Use clear language that reflects your understanding of medical terminology while keeping it professional.
Apply Through Our Website: We encourage you to submit your application through our website. It’s the best way for us to receive your details and ensures you’re considered for the role. Plus, it’s super easy!
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 information 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.