[Remote] Pharmacovigilance Training & SOP Associate
Note The job is a remote job and is open to candidates in USA. ICON plc is a world-leading healthcare intelligence and clinical research organization. The Pharmacovigilance Training Associate supports the development and maintenance of quality standards documents within the Pharmacovigilance department and coordinates training of staff to ensure compliance and inspection readiness.
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
- Support Pharmacovigilance leadership as needed Skills
- 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
- Proficiency with Veeva eLMS
- Proficiency with Veeva eDMS Benefits
- 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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others. Company Overview
- ICON Strategic Solutions is the global leading provider of Functional Service Provision (FSP) services. It was founded in undefined, and is headquartered in Dublin , GB, with a workforce of 10001+ employees. Its website is https//www.iconplc.com/services/strategic-solutions/. Company H1B Sponsorship
- ICON Strategic Solutions has a track record of offering H1B sponsorships, with 1 in 2023, 1 in 2022, 2 in 2021, 3 in 2020. Please note that this does not guarantee sponsorship for this specific role. Apply To this Job
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