Data Base Quality Control Operator, Pharma (Adverse Event Intake) European Native Speaker

JOB DESCRIPTION

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.

We are looking for Data Base Quality Coordinator, withforeign language expertise to join the world’s leading comprehensive pharmaceutical safety services organization on a fast-growing team performing medical information call centre services. We are seeking the best talent native in the requested language with very good command of English to perform his/her activity in the safety area (Adverse Events in Pharmacovigilance sector). Specific Training will be given in Safety area for Pharma products.

Summary:

The Data Base Quality Coordinator will be responsible to review, assess and process safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties, following applicable regulations SOPs and internal guidelines under guidance and support of senior operation team members.

Key responsibilities:

• Assist in processing of Lifecycle Safety data by collecting and tracking incoming Adverse Events(AE)/endpoint informatio, determining initial/update status of incoming events, tracking timelines for completion of event processing, distributing event information to appropriate project personnel in the workflow for continued processing, review and preparation of endpoint documentation
• Creating, maintain and track case folders, filing, retrieving and distribution of case folders to operations team members, assisting in maintenance of document control storage and relevant applications/systems as directed.
• Process safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.

• To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming.
• AdverseEvents(AE)/endpoint information.
• Determining initial/update status of incoming events.
• Coding AE and Products, writing narratives, Literature related activities as per internal/ project timelines.

• Ensure to meet quality standards per project requirements.
• Ensure to meet productivity and delivery standards per project requirements.
• To ensure compliance to all project related processes and activities.
• Creating, maintaining and tracking cases as applicable to the project plan.
• Identify quality problems, if any, and bring them to the attention of a senior team member.

• To demonstrate problem solving capabilities.
• Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes.
• 100% compliance towards all people practices and processes
• Perform other duties as assigned.

Minimum Required Education and Experience

• Must be Fluent in English plus one other language from – French or Spanish or Italian or Dutch or German.
• Bachelor’s Degree in scientific or healthcare area(preferably).

Skills and Abilities

• Excellent attention to detail and accuracy.
• Good knowledge of medical terminology.
• Working knowledge of applicable Safety Database.
• Self-motivated and flexible.

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.