Regulatory Reporting Specialist

IQVIA Safety Operations team play an important part in the design, build and execution of end-to-end safety solutions for major pharmaceutical companies and their post market products around the world. We are proud to be an international, diverse team based across the world, with ‘safety hubs’ in Ireland, Poland, Austria, Portugal, Slovakia, Spain, India and USA. Each new joiner is supported by a nurturing management team, collaborative colleagues as well as a clear career ladder with plenty of opportunities to allow you to grow, adapt and shine. 

You will benefit from joining the largest safety department in the world and working within an industry-leading, best-practice environment. To ensure you contribute to the business and grow your career, you will also benefit from ongoing training and development from our in-house safety experts to plan and progress your career. 

RESPONSIBILITIES 

• Regulatory Reporting Specialist provides comprehensive safety services across the lifecycle of pharmaceutical compounds and medical devices, from first in human clinical trials through post-approval, marketed product, and regulatory safety requirements.

• Collects, tracks, and reports adverse events or clinical outcomes; analyzes and reports aggregate safety data; performs safety surveillance; and performs benefit-risk evaluation and planning. 

• Provides data gathering, entry, and reporting services on behalf of contracted customers, including both clinical trial and marketed product safety activities.

• Triages, tracks, and processes safety data; assesses safety data for report-ability to the client safety department or relevant regulatory bodies; maintains communication (phone, fax, email) with investigative sites or marketed product reporters to obtain accurate data regarding safety events; and contributes to lifecycle safety deliverables.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES 

• Bachelor’s Degree in a Life Science is required.

• Excellent written and verbal skills in English

• Willingness and aptitude to learn new skills across our Lifecycle Safety service lines. 

• Excellent attention to detail and accuracy maintaining consistently high-quality standards. 

• Excellent organizational skills and time management skills. 

• Ability to establish and maintain effective working relationships with coworkers, managers and clients. 

• Ability to work effectively on multiple projects simultaneously, organize own workload and effectively manage competing priorities. 

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.