Clinical Safety Manager

2 days ago

London, United Kingdom Medpace Full time

Our 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 London. 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.
Manage Clinical Safety activities and multiple large programs
Manage 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; Create safety management plans dependent upon client;
Bachelor’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 CCDS/RMP/SmPC writing and maintenance;
Comprehensive knowledge of global clinical safety regulatory requirements;
Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV 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 its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.
Flexible work environment
Competitive compensation and benefits package
Competitive PTO packages
Structured career paths with opportunities for professional growth
Company-sponsored employee appreciation events
Employee health and wellness initiatives
Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility

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