Clinical Safety Manager

Responsibilities

• Manage clinical safety activities and multiple large-scale programs
• Oversee clinical safety case management and aggregate reporting to ensure high-quality client delivery
• Manage relationships with clients and internal stakeholders by providing expert safety knowledge
• Provide safety reviews of clinical study documents, including protocols, study reports, and marketing application components
• Create client-specific safety management plans
• Support business development through presentations to prospective sponsors, participation in audits, and generation of scope of work and cost estimates
• Write and maintain departmental SOPs and Work Instructions

Requirements

• Bachelor's degree or equivalent
• Proven clinical safety experience, including managing activities for multiple programs
• Experience in project management and ideally line management
• Comprehensive knowledge of global clinical safety regulatory requirements
• Experience in PSMF generation and maintenance
• Experience in CCDS, RMP, and SmPC writing and maintenance
• Strong leadership, mentoring, and motivational skills
• Excellent verbal and written communication skills

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. Our mission is to accelerate the global development of safe and effective medical therapeutics through a scientific and disciplined approach. Headquartered in Cincinnati, Ohio, Medpace employs more than 6,000 people across 40+ countries.