Pharmacovigilance Training Specialist
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 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.
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.
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.
Are you a current ICON Employee? Please click here to apply
