ICON
Manager, Pharmacovigilance SOPs & Training
United States · Remote (restrictions not stated) · Full time
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About the role
Description from the employer’s posting. Check the employer’s page for the current version.
- EmployerICON
- LocationUnited States
- Work styleRemote (restrictions not stated)
- Employment typeFull time
- Employer posted
Pharmacovigilance Training Specialist
At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.
As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.
The Manager, Pharmacovigilance SOPs & Training supports the development and maintenance of quality standards documents within the Pharmacovigilance department. The Manager coordinates training of Pharmacovigilance staff on Pharmacovigilance quality standards and ensures that training documentation is inspection ready. The role supports audit and inspection readiness activities and liaises with relevant internal stakeholders, external service providers, and business partners as required.
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What You Will Do:
- 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.
Your Profile:
- 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.
Rewards & Benefits
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
- 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
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.
Are you a current ICON Employee? Please click here to apply
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At a glance
- Work styleRemote (restrictions not stated)
- Employment typeFull time
- Employer posted
- Added to ROLIVA
- Last checked
Skills in this posting
Skills ROLIVA found in the employer’s own description above. A mention is not a requirement.