Pharmacovigilance Associate

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.
• The successful candidate will have previous pharmaceutical industry experience, preferably in pharmacovigilance/drug safety, with knowledge of medical terminology, coding systems and using computerized information systems and standard application software (e.g. Windows, MS Office)..
• 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.

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.