Pharmacovigilance Associate
hace 6 días
As a Pharmacovigilance Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
You will be partnering with a pharmaceutical company committed to discovering and developing treatments that improve and save people´s lives. Working in this program you will feel challenged and supported to advance in your professional career while making a truly impact.
**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.
For ICON Strategic Solutions, may also include:
- 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**:
- Bachelor’s degree in a health, life sciences or other relevant field of study.
- Ability to gather, recommend and summarize data for reports, to find solutions to various administrative problems, and to prioritize work.
- Demonstrated interpersonal skills.- All employees must read, write and speak fluent English and host country language.
**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.