Clinical Safety Manager – Pharmacovigilance / Drug Safety

Overview

In this role you will oversee clinical safety activities for multiple programs within our European operations, guiding safety processes and collaborating with clients and internal stakeholders. You will review safety aspects of study documents and contribute to safety plans, while supporting business development and SOP creation. A strong leadership ethos and cross-functional teamwork will help you shape compliant, high-quality pharmacovigilance deliverables. This is a chance to advance your career in a global CRO with meaningful patient impact.

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 across multiple large programs
• Oversee safety case management and aggregate reporting to meet client needs
• Provide safety reviews of protocols, study reports, and marketing components
• Develop safety management plans tailored to each client
• Support business development through sponsor engagements, audits, and scoping/work estimates
• Draft departmental SOPs and Work Instructions

Key requirements

• Bachelor’s degree or equivalent with clinical safety experience
• Experience managing clinical safety activities for multiple programmes
• Experience writing departmental SOPs and Work Instructions
• Experience in PSMF generation and maintenance
• Experience in CCDS/RMP/SmPC writing and maintenance
• 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
• PSMF
• CCDS
• RMP

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