Medical Monitor - Ophthalmologist
LennTech are partnering with a global medical device client who are seeking a licensed Ophthalmologist to support clinical safety evaluation, post‑market vigilance, and device risk management for its diverse contact lens portfoli
o.
Job Summ
aryThe Medical Monitor / Medical Vigilance Officer / Medical Safety Officer will provide expert ophthalmic assessment of adverse events, support regulatory compliance for UK/EU/global vigilance obligations and enhance both pre-market & post‑market clinical evidence by contributing clinical insight into complaint trends, safety signals, and product investigations. Ultimately, ensuring the safety and integrity of clinical trials and global regulatory safety complian
ce.
Your responsibilities will incl
* ude: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 et
* c.).Review adverse event (AE) submissions for completeness, clarity, and appropriateness of severity and relatedness classification in a timely fashion to ensure compliance with reporting timeli
* nes.Serve as the primary medical contact for internal and external investigators and supporting person
* nel.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 timefra
* mes.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 stud
* ies.Contribute to benefit–risk assessments and documentation for product investigations and CAPA activities (as need
* ed).Support clinical assessments for risk management files and technical documentat
* ion.Work with RA and QA to review global complaints, AEs and failure r
* atesServe as SME for protocol, investigator brochure, study reports, etc. relative to safety endpoi
* nts.Provide safety input into Product Hazard assessments and evaluat
* ionsSupport R&D QA during audits for inquiries relating to AE and Product Complaint report
* ing.Participating in or facilitating Data Safety Monitoring Board (DSMB) rev
* iewsCollaborate with RA on review and assessment of documents of external origin (DOEO) and relevance to ongoing clinical activi
ties
Knowledge, Skills and Experie
* nce: Experience with medical device vigilance, safety reporting and/or Health Hazard Evalua
* tionsUnderstand standardized medical coding, GCP, ISO and regulatory reporting require
* mentsAbility to manage multiple projects and adjust to changing prior
* itiesExcellent communication skills, both verbal and written, including appropriate use of medical and scientific termin
* ologyOptometry or ophthalmology background/tra
ining
Experience/Educ
* ation:Licensed Ophthalmologist (GMC‑regist
* ered).At least 3 years of experience with pharmacovigilance, regulatory affairs or medical moni
* toringExperience in contact lens or medical device industry pre
ferred