Manager, Pharmacovigilance SOPs – Training

Job Description:

• Ensure compliance with internal procedures, regulatory requirements, and partner agreements to ensure inspection readiness
• Coordinate development, review, and maintenance of Pharmacovigilance quality standards documents
• Support management of documents through the approval lifecycle within document management systems
• Train Pharmacovigilance and external service provider/vendor staff as requested
• Assist with support and identification of cross functional specific SOPs requiring GPRM training
• Maintain Pharmacovigilance training records to ensure documentation is accurate, up to date, and inspection ready
• Support development and maintenance of Pharmacovigilance training programs and initiatives
• Provide technical expertise on Pharmacovigilance quality standards and training processes
• Identify quality issues, propose solutions, and escalate as appropriate
• Support Pharmacovigilance audit processes and inspections as needed
• Review and provide feedback on Pharmacovigilance documents and templates as requested
• Assist with updates to the Pharmacovigilance System Master File as applicable
• Collaborate with intradepartmental teams, business partners, and external service providers

Requirements:

• Proficiency in written and verbal English to effectively communicate in the workplace
• Strong verbal and written communication skills
• Strong organizational, time management, and problem-solving skills
• Demonstrated ability to work effectively within a team environment
• Proficiency in Microsoft Word, Excel, Outlook, and PowerPoint
• Knowledge of global Pharmacovigilance regulations (CFR/GVP), ICH Guidelines, and GCP
• Experience preparing and delivering training to a variety of audiences
• Experience working with learning management systems; proficiency with Veeva eLMS preferred
• Experience developing procedural documents and working with document management systems; proficiency with Veeva eDMS preferred
• Bachelor’s degree in a science or healthcare-related discipline, or equivalent experience
• Employment with ICON is contingent upon having the legal right to work in the country where the role is based

Benefits:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways