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.
**What you will be doing**:
- Perform processing for all types of safety events, medical information call handling activities and other medically related project information.
- Perform reconciliation of SAEs, literature surveillance, and data retrievals from the safety database. Supports the generation of aggregated safety reports, and Data Monitoring Committees (DMC) reviews.
- Ensure all ICON, Sponsor, and regulatory timeframes are met for the processing and reporting of safety information.
- Assist in ensuring the completion of all departmental project activities accurately in accordance with ICON standards, regulatory requirements, and contractual obligations to Sponsors.- Serve as safety reporting or safety reporting intelligence processor and/or lead for multiple safety reporting or safety reporting intelligence stand-alone projects, providing management support as designated.- Responsible for safety reporting or safety reporting intelligence activities on assigned projects, working in a customer focused approach and an audit and inspection ready mindset.- Demonstrate skills pertaining to client management, safety reporting, project scope, submission compliance, quality, and budget.- Coding Adverse Events in accordance to the applicable standard dictionary- Serve as quality complaint processor for assigned projects and monitor the process of returning samples for quality compliant and applicable tracking- Complete adverse event and/or product quality complaint cases follow-up in writing and/or by phone based on requirements for each Client.- Perform periodic reconciliation of adverse event and/or quality complaint cases received from different sources within the required deadlines
**You are**:
- G-Bachelor's Level Degree
- Applies considerable knowledge of company policies and procedures.
- Applies knowledge of working in safety databases Applies knowledge in pharmacovigilance.
**What ICON can offer you**:
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family's needs
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
