Clinical Safety Manager

Responsibilities

• Manage Clinical Safety activities and multiple large programs
• Oversee clinical safety case management and aggregate reporting responsibilities
• Manage relationships with clients and internal stakeholders by providing expert safety knowledge
• Provide safety review of clinical study documents, including protocols, study reports, and marketing application components
• Create safety management plans tailored to client needs
• Support business development activities, including presentations to prospective Sponsors and participation in Sponsor audits
• Write departmental SOPs and Work Instructions

Requirements

• Bachelor’s degree with 5 years of clinical safety experience, including project management
• OR Master's degree with 3 years of clinical safety experience, including project management
• Experience in PSMF generation and maintenance
• Experience in CCDS, RMP, and SmPC writing and maintenance
• Comprehensive knowledge of global clinical safety regulatory requirements
• Strong leadership, mentoring, and communication skills
• Ability to work independently in an office-based environment in Munich

Benefits

• Competitive compensation and benefits package
• Competitive PTO packages
• Structured career paths with opportunities for professional growth
• Flexible work environment
• Company-sponsored employee appreciation events
• Employee health and wellness initiatives

About the Company

Medpace is a full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Headquartered in Cincinnati, Ohio, Medpace employs more than 6,000 people across 40+ countries, leveraging therapeutic expertise to accelerate the global development of safe and effective medical therapeutics.