.Senior Pharmacovigilance Reporting AssociateApply locations Mexico, Mexico City time type Full time posted on Posted 8 Days Ago time left to apply End Date: January 12, 2025 (20 days left to apply) job requisition id JR126424 Senior Pharmacovigilance Reporting Associate, Hybrid - Mexico (Mexico City only)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.We are currently seeking a Senior Pharmacovigilance Reporting Associate to join our diverse and dynamic team. As a Senior Pharmacovigilance Reporting Associate at ICON, you will be essential in ensuring accurate and timely reporting of safety data related to pharmaceutical products. You will work closely with cross-functional teams to enhance the organization's pharmacovigilance reporting processes and maintain compliance with regulatory standards.The work schedule for this role is hybrid, Monday to Friday; you will be working 03 days in the office and 02 days at home. Office attendance 3 days per week is compulsory.What You Will Be Doing:Preparing and submitting adverse event reports and safety data in accordance with regulatory requirements and internal policies, ensuring accuracy and completeness.Collaborating with clinical and regulatory teams to review and analyze safety data, identifying trends and potential safety signals for further investigation.Assisting in the preparation of periodic safety update reports (PSURs), annual reports, and other regulatory documents to ensure compliance with reporting obligations.Monitoring timelines for safety report submissions and proactively managing any delays or issues that may arise in the reporting process.Maintaining and updating pharmacovigilance databases, ensuring the integrity and quality of safety data through meticulous data entry and validation.Providing training and support to junior team members on reporting procedures and pharmacovigilance regulations to enhance team capabilities.Engaging in audits and inspections by regulatory authorities, ensuring readiness and adherence to all relevant pharmacovigilance reporting requirements.Staying informed about changes in regulatory guidelines and industry standards to ensure ongoing compliance and best practices in pharmacovigilance reporting.Your Profile:Bachelor's degree in life sciences, pharmacy, or a related field. An advanced degree is preferred.2-3 years extensive experience in pharmacovigilance or drug safety reporting, with a strong understanding of relevant regulations and guidelines.Proven ability to prepare and submit accurate adverse event reports and safety data in a timely manner.Strong analytical skills, with the ability to interpret safety data and identify trends or issues requiring further action