Manager, Pharmacovigilance SOPs & Training

ICON Strategic Solutions provides sponsor-dedicated services supported by global expertise. The Manager, Pharmacovigilance SOPs & Training supports the development and maintenance of Pharmacovigilance quality standards, coordinates staff training, maintains inspection-ready documentation, and supports audit and inspection readiness activities.

Responsibilities

Ensure compliance with internal procedures, regulatory requirements, and partner agreements to ensure inspection readiness at all times

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

Preferred

proficiency with Veeva eLMS preferred

proficiency with Veeva eDMS preferred

Veeva eLMS

Veeva eDMS

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

Company

Outsourced clinical development and commercialization services for life sciences

Dublin , GB

https://www.iconplc.com/services/strategic-solutions/

10001+ employees

Qualifications

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

Experience developing procedural documents and working with document management systems

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

Proficiency with Veeva eLMS preferred

Proficiency with Veeva eDMS preferred

Required skills

Pharmacovigilance Regulations (CFR/GVP), ICH Guidelines, Clinical Practice (GCP), Training Delivery, Procedural Documentation, Veeva eLMS, Veeva eDMS, Microsoft Word, Microsoft Excel, Microsoft Outlook, Microsoft PowerPoint

Preferred skills

proficiency with Veeva eLMS preferred, proficiency with Veeva eDMS preferred

Experience

Mid level