Pharmacovigilance Reporting Associate (Submission)
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
As a Pharmacovigilance Reporting Associate at ICON, you will be responsible for the accurate and timely preparation of safety reports related to clinical trials and post-marketing activities.
What You Will Do:
You will take responsibility for pharmacovigilance and drug safety deliverables, applying your skills to ensure quality and efficiency.
Key responsibilities include:
• Preparing and reviewing safety reports, including periodic safety updates and individual case safety reports, ensuring accuracy and compliance with regulatory standards.
• Collecting and analyzing adverse event data from clinical trials and post-marketing sources to support the preparation of comprehensive safety reports.
• Maintaining up-to-date knowledge of regulatory requirements and industry best practices related to pharmacovigilance reporting.
• Collaborating with cross-functional teams, including clinical, regulatory, and data management, to gather necessary information and resolve any reporting issues.
• Ensuring the timely submission of safety reports to regulatory authorities and sponsors, adhering to established deadlines and guidelines.
Your Profile:
You will bring relevant pharmacovigilance and drug safety experience, along with the following qualifications and skills.
Required qualifications and experience:
• Bachelor's degree in life sciences, pharmacy, or a related field.
• Experience in pharmacovigilance or drug safety, with a solid understanding of safety reporting processes and regulatory requirements.
• Excellent attention to detail and organizational skills, with the ability to prepare and