IQVIA

Regulatory Reporting - Operations Specialist Manager (Pharmacovigilance) - Remote

5 days left

Company
IQVIA
Location
Dublin
Posted
09 Feb 2021
Closes
11 Mar 2021
Ref
R1184042
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

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

#LI-CF3

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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.

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