Manager, Pharmacovigilance SOPs & Training

ICON Strategic Solutions; United States; On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Annual leave

Health insurance

Retirement planning

LifeWorks EAP

Life assurance

Country-specific benefits

Job summary

ICON Strategic Solutions is seeking a Pharmacovigilance Training Specialist to strengthen our sponsor-dedicated pharmacovigilance model. You will design, deliver, and maintain training on quality standards within PV, ensuring inspection readiness and alignment with CFR/GVP, ICH, and GCP.

You will collaborate with internal teams and external providers, manage training documentation, and support audits and inspections while promoting continuous improvement across the Pharmacovigilance function.

Qualifications

• Experience preparing and delivering training to diverse audiences.
• Familiarity with learning management systems; Veeva preferred.
• Knowledge of CFR/GVP, ICH Guidelines and GCP in pharmacovigilance.
• Bachelor’s degree in science or healthcare-related discipline or equivalent.

Responsibilities

• Ensure compliance with internal procedures, regulatory requirements, and partner agreements.
• Coordinate development, review and maintenance of PV quality standards documents.
• Manage training documentation through approval lifecycle in systems.
• Train PV staff and external service providers as requested.
• Support cross-functional SOP training and GPRM initiatives.
• Maintain training records and ensure inspection readiness.
• Support PV audits and inspections as needed.
• Review and provide feedback on PV documents and templates.
• Collaborate with internal teams and external partners.

Skills

English proficiency

Written communication

Verbal communication

Organizational skills

Time management

Problem solving

Teamwork

MS Word

MS Excel

Outlook

PowerPoint

GVP CFR ICH GCP knowledge

Training delivery

LMS experience

Education

Science or healthcare degree

Tools

Veeva eLMS

Veeva eDMS

Document management systems

Job description

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.

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 elevate 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.

What ICON Can Offer You

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our Benefits Examples Include

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.