Pharmacovigilance Reporting Specialist

Roles & Responsibilities
• Lead safety submission activities for complex pharmacovigilance projects
• Prepare and submit safety reports including PSURs and ICSRs in compliance with global regulatory standards
• Oversee safety submission projects ensuring timelines, scope, and quality standards are met
• Conduct detailed data analysis to identify safety trends and assess product risk profiles
• Collaborate with cross-functional teams for timely adverse event reporting
• Ensure compliance with global pharmacovigilance regulations and internal SOPs
• Provide training and guidance to team members on PV reporting processes
• Maintain inspection readiness and high-quality documentation standards

Qualification
• Bachelor’s degree in Life Sciences / Pharmacy or related field
• Advanced degree preferred

Experience
• Minimum 6 years of experience in pharmacovigilance reporting within clinical/pharmaceutical environment
• Strong safety submission experience (PSURs, ICSRs)
• Minimum 1 year of project management experience including financial and scope oversight

Skills
• Strong analytical and data interpretation skills
• Proficiency in safety databases and reporting tools
• In-depth knowledge of global PV regulations and reporting requirements
• Excellent communication and stakeholder management skills
• Strong quality focus and compliance orientation
• Ability to manage multiple projects in a matrix environment

About the Organization
ICON plc is a global healthcare intelligence and clinical research organization dedicated to advancing clinical development and improving patient outcomes. The company fosters an inclusive culture, innovation-driven environment, and offers competitive global benefits focused on employee well-being and professional growth.