Manager, Pharmacovigilance SOPs – Training

🔥 1 minute ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

👻 Ghost score 10%

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

• Ensure compliance with internal procedures, regulatory requirements, and partner agreements to ensure inspection readiness • 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

🎯 Requirements

• 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

🏖️ 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