Medical Monitor - Contract Role - 12 months

Job description

At CooperVision, a division of CooperCompanies, we’re driven by a unifying purpose to help people to experience life’s beautiful moments. We are connected through our shared values - dedicated, innovative, friendly, partners, and do the right thing. As a leading global manufacturer of contact lenses, we are committed to helping improve the way people see each day. Through our diverse lens portfolio, we tackle the toughest vision challenges – including astigmatism, presbyopia, and childhood myopia. We offer the most complete collection of spherical, toric, and multifocal products available, enabling us to fit 99% of all contact wearers. Learn more at www.coopervision.com . Temp contractor: 12 months: Location: San Ramon: Job Summary: Ensure the safety and integrity of clinical trials and global regulatory safety compliance. Essential Functions & Accountabilities: 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...