Clinical Safety Manager - Pharmacovigilance / Drug Safety
1 day ago
Stirling
Job SummaryOur European activities are growing rapidly, and we are currently seeking a full-time, office-based Clinical Safety Manager to join our UK team and to be based at our growing UK office in Stirling. This position plays a key role in the pharmacovigilance process at Medpace. Working in a team to accomplish tasks and projects that are instrumental to the company’s success.If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.ResponsibilitiesManage Clinical Safety activities and multiple large programsManage relationships with clients and internal stakeholders by providing expert safety knowledge;Oversee clinical safety case management and aggregate reporting responsibilities to ensure client needs are fulfilled to a high quality;Provide safety review of clinical study documents, including protocols, study reports; and marketing application components.Create safety management plans dependent upon client;Attend business development activities such as presentations to prospective Sponsors, participation in Sponsor audits, generation of scope of work and cost estimatesWrite departmental SOPs and Work InstructionsQualificationsBachelor’s degree or equivalent and clinical safety experience, including project management and ideally line management experience;Previous experience of managing clinical safety activities for multiple programmes;Experience in writing departmental SOPs and Work Instructions;Experience in PSMF generation and maintenance;Experience in CCDS/RMP/SmPC writing and maintenance;Comprehensive knowledge of global clinical safety regulatory requirements;Excellent verbal and written communication skills;Strong leadership, mentoring, and motivational skills;Exceptional teamwork skills;Ability to work independently.Medpace 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