Medical Monitor

Job title: Medical Monitor

Department: R&D Clinicals (CooperVision)

Location: Southampton Hampshire UK

GLS: T04

Working hours: 37.5 hours per week Monday to Friday

A brighter future awaits you

CooperVision is one of the worlds leading manufacturers of soft contact lenses with a presence in over 100 countries. Being part of CooperVision means helping improvethe way people see each day. Its more than makingcontact lenses its about giving lens wearers freedom andconfidence to move about their daily lives. Were all about bright futures for our people and those who wear our contact lenses.

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 etc.) while serving as the primary medical contact for internal and external investigators.

Your responsibilities will include:

• 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.

A full job description is available upon request.

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:

Youll 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. To help us achieve our goals well give you everything you need to help you achieve yours.

We also provide access to LinkedIn Learning to help you develop in you career and grow with CooperVision.

What you can expect:

As a CooperVision employee youll 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. With our CooperPride African Descent Womans Impact Network and Mind Body and Wellbeing Employee Resource Groups we offer opportunities for employees to learn and grow within an inclusive and safe space.

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 view all other opportunities.

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