At a Glance
- Tasks: Ensure safety compliance in clinical trials and review adverse event submissions.
- Company: Join CooperVision, a leading manufacturer of soft contact lenses.
- Benefits: Competitive salary, private medical insurance, 25 days holiday, and wellness support.
- Other info: Diverse and inclusive culture with opportunities for personal and professional growth.
- Why this job: Make a real impact on eye health and contribute to innovative medical solutions.
- Qualifications: 7-10 years in pharmacovigilance or medical monitoring; optometry background preferred.
The predicted salary is between 36000 - 60000 £ per year.
CooperVision is one of the world’s leading manufacturers of soft contact lenses with a presence in over 100 countries. Being part of CooperVision means helping improve the way people see each day. It’s more than making contact lenses, it’s about giving lens wearers freedom and confidence to move about their daily lives.
Job Summary – What to expect
As a Medical Monitor in our 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), while serving as the primary medical contact for internal and external investigators.
Responsibilities
- Reviewing adverse event (AE) submissions for completeness, clarity, and appropriateness of severity and relatedness classification in a timely fashion to ensure compliance with reporting timelines, and reporting Serious Adverse Event submissions to the relevant bodies.
- Performing monthly reviews of pre‑market AEs with RA.
- Generating 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.
- Supporting R&D QA during audits for inquiries relating to AE and Product Complaint reporting, and participating in or facilitate Data Safety Monitoring Board (DSMB) reviews.
- Developing and overseeing delivery of safety training materials.
- Collaboration with RA on review and assessment of documents of external origin (DOEO) and relevance to ongoing clinical activities.
About you
We are looking for someone with:
Knowledge, Skills and Abilities
- Experience with safety reporting and/or Health Hazard Evaluations.
- Understanding of 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
- Ideally 7‑10 years of experience with pharmacovigilance, regulatory affairs or medical monitoring.
- Experience in contact lens or medical device industry preferred.
- MD ophthalmologist with active license.
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! We are committed to our employees’ personal and professional development and offer extensive training to support your career growth and help every individual to reach their full potential.
What you can expect
As a CooperVision employee, you’ll be welcomed into a diverse and progressive global business. We appreciate how important fostering a diverse and inclusive culture is and how different perspectives add value and contribute to our success.
Application
All suitably qualified applicants will receive equal consideration and opportunities from CooperVision. If you like what you see, take the first step towards your Brighter Future and apply today!
Medical Monitor / Medical Vigilance Officer / Medical Safety Officer in Southampton employer: CooperVision
CooperVision is an exceptional employer located in Southampton, Hampshire, offering a vibrant work culture that prioritises employee wellbeing and professional growth. With a comprehensive benefits package, including private medical insurance, generous holiday allowance, and access to wellness resources, we are dedicated to fostering a diverse and inclusive environment where every team member can thrive and contribute to our mission of improving vision for people worldwide.
StudySmarter Expert Advice🤫
We think this is how you could land Medical Monitor / Medical Vigilance Officer / Medical Safety Officer in Southampton
✨Tip Number 1
Network like a pro! Reach out to professionals in the medical monitoring field on LinkedIn or at industry events. A friendly chat can open doors and give you insights that job descriptions just can't.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of GCP, ISO, and regulatory requirements. We want to see you shine, so practice explaining how your experience aligns with the role's responsibilities.
✨Tip Number 3
Showcase your communication skills! During interviews, be clear and concise when discussing your past experiences. Remember, we’re looking for someone who can articulate complex medical concepts in an understandable way.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you’re genuinely interested in joining the CooperVision team.
We think you need these skills to ace Medical Monitor / Medical Vigilance Officer / Medical Safety Officer in Southampton
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Medical Monitor role. Highlight your experience in safety reporting and any relevant skills that match the job description. We want to see how your background fits with what we’re looking for!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you’re passionate about the role and how your experience aligns with our needs. Don’t forget to mention your understanding of GCP and regulatory requirements!
Showcase Your Communication Skills:Since excellent communication is key for this role, make sure your application reflects your ability to convey complex information clearly. Use appropriate medical terminology where necessary, but keep it accessible!
Apply Through Our Website:We encourage you to apply through our careers page. It’s the best way to ensure your application gets to us directly. Plus, you can check out other opportunities while you’re there!
How to prepare for a job interview at CooperVision
✨Know Your Stuff
Make sure you brush up on your knowledge of safety reporting, GCP, and regulatory requirements. Familiarise yourself with the specific protocols and guidelines relevant to the medical device industry, especially in relation to contact lenses. This will show that you're not just interested in the role but also understand the critical aspects of it.
✨Showcase Your Experience
Prepare to discuss your past experiences in pharmacovigilance or medical monitoring. Be ready to share specific examples of how you've handled adverse event submissions or collaborated with regulatory affairs. This will help demonstrate your expertise and how it aligns with what CooperVision is looking for.
✨Communicate Clearly
Since excellent communication skills are a must, practice articulating complex medical concepts in a clear and concise manner. Use appropriate medical terminology but ensure that you can explain it simply if needed. This will highlight your ability to communicate effectively with both internal teams and external investigators.
✨Ask Insightful Questions
Prepare thoughtful questions about the role and the company culture. Inquire about the team dynamics, ongoing projects, or how they approach safety training materials. This shows your genuine interest in the position and helps you assess if it's the right fit for you.
