Website Icon PLC ltd
Post Name: Pharmacovigilance Manager
About the role:
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
As a Manager, Pharmacovigilance at ICON, you will be responsible for overseeing the pharmacovigilance activities, ensuring the safety and efficacy of clinical trial products throughout their lifecycle.
What You Will Do:
Your focus will be on coordinating pharmacovigilance and drug safety delivery, resolving issues, and developing team capability.
Key responsibilities include:
Leading the pharmacovigilance team in the collection, evaluation, and reporting of adverse events, ensuring compliance with regulatory guidelines and internal standards.
Developing and implementing pharmacovigilance processes and policies to enhance the efficiency and effectiveness of safety monitoring activities.
Collaborating with clinical, regulatory, and quality assurance teams to ensure comprehensive safety assessments and timely reporting of safety data.
Providing training and guidance to team members and stakeholders on pharmacovigilance regulations, practices, and procedures.
Monitoring and analyzing safety data trends, preparing risk assessments, and presenting findings to relevant stakeholders.
Ensuring that all pharmacovigilance activities are conducted in accordance with global regulatory requirements and internal quality standards.
Your Profile:
Bachelor’s degree or higher in Life Sciences, Pharmacy, Medicine, Nursing, or a related healthcare/scientific discipline.
Strong Pharmacovigilance experience with strong exposure to case processing, safety reporting, aggregate reporting, PV operations, or related drug safety activities.
Mandatory line management experience leading a small to medium-sized team, including workload management, coaching, mentoring, and staff development.
Hands-on experience conducting performance reviews, setting objectives, providing performance feedback, managing employee development plans, and supporting succession planning.
Project management experience (preferred) with responsibility for project delivery, resource planning, workload forecasting, risk management, and stakeholder communication.
Strong understanding of global Pharmacovigilance regulations, GVP/GCP requirements, SOPs, quality systems, and regulatory compliance expectations.
Demonstrated ability to manage resources and capacity planning, ensuring project deliverables, timelines, and quality standards are consistently met.
Experience in metric generation, reporting, data analysis, trend identification, and continuous process improvement initiatives.
Proficiency in Microsoft Excel, PowerPoint, Word, and reporting/analytics tools, with the ability to prepare management reports, dashboards, presentations, and business updates.
Excellent written and verbal communication skills, with experience interacting with clients, senior management, cross-functional teams, and external stakeholders.
Proven ability to deliver presentations, lead meetings, conduct training sessions, and influence stakeholders across different levels of the organization.
Experience supporting recruitment, onboarding, employee development, audits/inspections, and quality improvement initiatives within a regulated environment.
