Manager, Pharmacovigilance SOPs & Training
ICON · Blue Bell +1 more
SafetyFull-timeCompany career page
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Role summary
Manager overseeing pharmacovigilance standard operating procedures and training programs at a clinical research organization. Responsibilities include developing quality standards documents, coordinating staff training, maintaining inspection readiness, and supporting audit and regulatory activities.
What they're looking for
- Knowledge of global pharmacovigilance regulations (CFR/GVP), ICH Guidelines, and GCP
- Experience developing procedural documents and working with document management systems
- Experience preparing and delivering training to diverse audiences
- Bachelor's degree in science or healthcare-related discipline, or equivalent experience
- Proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint)
- Strong written and verbal English communication skills
- Experience with learning management systems; Veeva eLMS proficiency preferred
What you'll be doing
- Develop, review, and maintain pharmacovigilance quality standards documents and templates
- Coordinate training delivery for pharmacovigilance staff and external service providers on quality standards
- Maintain training records and documentation to ensure inspection readiness
- Support audit processes, inspections, and regulatory compliance activities
- Identify quality issues, propose solutions, and escalate to management as needed
Privacy & handoff
This role links to ICON's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.