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Operations Specialist 2 in Regulatory Reporting

1 week ago

Dublin, Ireland IQVIA Full time

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 specialist in one or more areas. You will provide oversight on small to medium service operational projects and act as mentor to junior members of staff. The position is office based (hybrid) in Dublin.

MAIN RESPONSIBILITIES

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 requirement as per project.

Triages, tracks, and processes safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirement.

Liaise with relevant stakeholders to facilitate expedited reporting. Maintains communication with investigative sites or marketed product reporters to obtain accurate data regarding safety events.

Liaise with manager for regulatory tracking requirements and electronic reporting.

Ensure to meet quality, productivity and delivery standards per project requirements.

Ensure compliance to all project related processes and activities.

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

Bachelor's Degree in Healthcare or Life Science discipline

At least 3 years of relevant work experience, inclusive of up to 3 years of relevant experience

Excellent knowledge of medical terminology

Excellent written and verbal skills in English

In depth knowledge and understanding of applicable Safety Database

Excellent organizational skills, time management skills, attention to detail and accuracy.

Excellent working knowledge of Microsoft Office and web-based applications.

Very good Time-management and leadership skills.

Excellent verbal/written communication skills.

Self-motivated, flexible, receptive to changing process demands.

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. Learn more at