Overview
In this role you will oversee pharmacovigilance activities for multiple programs within Medpace UK, supporting high-quality safety outcomes for clients. You will work with cross-functional teams to review study documents and safety components, and you’ll contribute to safety planning, audits, and scope/cost estimation efforts. You’ll manage safety programs and mentor junior staff while maintaining regulatory compliance across global requirements. This is an opportunity to shape safety processes in a fast-growing European footprint and advance your leadership in pharmacovigilance.
Pay / Benefits
- 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
Responsibilities
- Manage Clinical Safety activities for multiple programs
- Maintain strong client and internal stakeholder relationships with expert safety input
- Oversee clinical safety case management and aggregate reporting to meet client needs
- Provide safety reviews of protocols, study reports, and marketing components
- Create safety management plans tailored to client requirements
- Participate in business development activities including sponsor presentations, audits, and scope/cost estimation
- Draft departmental SOPs and Work Instructions
Key requirements
- Bachelor’s degree or equivalent with clinical safety experience
- Experience managing clinical safety activities for multiple programs
- Experience writing 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
- Strong leadership, mentoring, and teamwork skills
- Ability to work independently
- leadership
- mentoring
- teamwork
- pharmacovigilance
- safety review of clinical study documents
- PSMF generation and maintenance
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