Operations Specialist 2 in Regulatory Reporting, Dublin
Client:
IQVIA
Location:
Dublin, Ireland
Job Category:
Other
EU work permit required:
Yes
Job Reference:
315ff1ef9462
Job Views:
7
Posted:
15.03.2025
Expiry Date:
29.04.2025
Job Description:
IQVIA Safety Operations 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. Being a part of IQVIA Safety Operations, the Regulatory Reporting team provides data gathering, entry, and reporting services on behalf of contracted customers, including both clinical trial and marketed product safety activities.
As Operations Specialist 2, you will apply knowledge and expertise including complex decision-making activities to review, assess, and process Safety data and information across service lines. Recognized as a specialist in one or more areas, you will provide oversight on small to medium service operational projects and act as a mentor to junior members of staff. The position is office-based (hybrid) in Dublin.
MAIN RESPONSIBILITIES
1. Assesses Safety data for reportability to the client safety department or relevant regulatory bodies (regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups) per legislation, within timelines and in a format compatible to meet requirements as per project.
2. Triages, tracks, and processes safety data according to applicable regulations, guidelines, Standard Operating Procedures (SOPs), and project requirements.
3. Liaise with relevant stakeholders to facilitate expedited reporting. Maintains communication with investigative sites or marketed product reporters to obtain accurate data regarding safety events.
4. Liaise with manager for regulatory tracking requirements and electronic reporting.
5. Ensure to meet quality, productivity, and delivery standards per project requirements.
6. Ensure compliance to all project-related processes and activities.
7. Build a positive, collaborative team environment with Safety team members, lead by example, provide training and mentoring for less experienced team members and operations staff, assist Operations Manager as a backup when needed.
MAIN REQUIREMENTS
1. Bachelor's Degree in Healthcare or Life Science discipline
2. At least 3 years of relevant work experience
3. Excellent knowledge of medical terminology
4. Excellent written and verbal skills in English
5. In-depth knowledge and understanding of applicable Safety Database
6. Excellent organizational skills, time management skills, attention to detail, and accuracy.
7. Excellent working knowledge of Microsoft Office and web-based applications.
8. Very good time-management and leadership skills.
9. Self-motivated, flexible, receptive to changing process demands.
10. Proven ability to work independently and autonomously with policies and practices.
IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world.
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