Regulatory Reporting – Operations Specialist Manager

Be a part of a global team to help ensure the safety profile of a COVID-19 vaccine with opportunities to improve worldwide public health.

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.

Job overview:

• Support Regulatory reporting global initiatives

• 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 

• Assess 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

• Subject Matter expert – process improvement

Qualifications: 

• 5 years +, pharmacovigilance experience

• Lifescience or Healthcare degree

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At IQVIA, 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. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.