Clinical Safety Coordinator - Pharmacovigilance / Drug Safety
Medpace · London, England ·
Job SummaryAt Medpace, our European Pharmacovigilance (PV) activities are growing rapidly. As such, we are searching for motivated individuals to join our Clinical Safety team in London. Working as part of a high performing group alongside Medical Monitors, Quality Assurance, Clinical Trial Management and others, this position plays a key role at Medpace to accomplish tasks and work on projects that are instrumental to the development of life changing medicines.
If you want an exciting career where you can apply yourself to a variety of opportunities and develop new skills, then this is the opportunity for you! ResponsibilitiesCollect, process, and track serious adverse event (SAE) reportsGenerate safety narratives and queriesSafety Database data entryPerform quality control of safety casesGenerate Investigator Safety LettersSAE reconciliation between safety database and clinical databaseTMF uploads and quality control reviewPreparation of clinical safety documents as required (i.e., safety management plan, periodic safety reports and presentations)Attending internal and external meetings, as required (including sponsor TCs and audits/inspections)Leading clinical trial projects (ensure client deliverables are met, provide oversight and compliance reports)Additional ResponsibilitiesDevelop presentation material and present during face-to-face Sponsor meetings (i.e., Kick-off Meetings, Investigator Meetings)Coordinate final medical review of study report narratives and submission to Medical WritersDevelop drafts of adjudication material (i.e., charter, reporting materials)Provide periodic safety summaries to project Data Manager, Clinical Trial Manager, and Medical MonitorTrain new Clinical Safety Coordinators on safety reporting responsibilitiesCoordinate safety responsibilities for aggregate reporting purposes (e.g., ensure timely data entry, tracking of pending cases, collaborate with Medical Monitor and Regulatory Affairs)QualificationsMinimum Bachelor's life science degree2+ years of Clinical Trial Pharmacovigilance experienceWorking knowledge of Safety Databases (Argus is desirable)Demonstrate advanced knowledge of medical terminology, global safety reporting requirements and Good Clinical Practice (GCP) GuidelinesExposure to working on global trials as part of a multidisciplinary teamMedpace OverviewMedpace is a full-service clinical contract research organization (CRO) providing phase l-lV clinical development services to the biotechnology, pharmaceutical, and medical device industries.
Our mission is to accelerate the global development of safe and effective medical therapeutics through the advancement of clinical research. We leverage in-country regulatory and therapeutic expertise across all major therapeutic areas including oncology, cardiology, metabolic, endocrinology, central nervous system, and anti-viral and anti-infective.
Headquartered in Cincinnati, Ohio, we employ more than 6,500 people across 40+ countries. Why Medpace? When you join Medpace, you become part of an innovative team that brings cutting-edge therapies to market while building a meaningful and rewarding career focused on scientific excellence and improving patient outcomes around the world through continuous learning and cross-functional collaboration.
Purpose-Driven WorkWork alongside physicians, scientists, and industry-leading experts committed to advancing the global development of medical therapeutics through clinical research excellenceCollaborative CultureContribute to an interactive team environment that empowers decision making, creative thinking, and continuous learning through open communication and mutual trust.
Leadership throughout Medpace is both accessible and approachableContinuous Growth & DevelopmentOffice based environment with on-site mentorsDefined career paths with clear advancement opportunitiesIndustry renowned onboarding and training programs designed to accelerate professional developmentOngoing training and continuous learning opportunities throughout your careerAn environment that encourages employees to influence change, contribute ideas, and grow quicklyOther Employee BenefitsCompetitive compensation programs that recognize and reward performanceComprehensive health, wellness, retirement, and PTO benefitsOffice based culture with occasional WFH that provides flexibility for eligible positions after trainingCompany-sponsored social events Please note benefits may vary based on country.
What to Expect NextA Medpace team member will review your application and if your profile matches our current needs, you will be contacted for an interview. While we review all applications carefully, we are unable to respond to every applicant, and only candidates selected for interviews will be contacted. Job SummaryCategory: Clinical Safety