Safety Aggreg Report Spec 1 - (R1050138) in Research Triangle Park, NC at IQVIA™

Date Posted: 11/2/2018

Job Snapshot

Job Description

Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.


Contribute and/or provide administrative and technical support to Safety Aggregate Reporting and Analytics (SARA) deliverables including safety aggregate reports, literature surveillance, and signal detection activities.
 Provide mentorship and training to less experienced resources.
 Assist with metrics management, reconciliation, and audit and training tasks, monitor SARA specific mailboxes and other administrative activities as assigned.
 Prepare final formatting/compilation of document(s) including necessary attachments/appendices.
 Contribute and/or provide support to SARA deliverables and have responsibility for completion of the deliverable in compliance with all applicable service level agreements.
 Contributes to small to medium aggregate reports, including but not limited to PBRERs, DSURs, PADERs, ACOs, and six monthly line listings; author responses to regulatory agency/PRAC inquiries, as required.
 Contributes in the conduct of ongoing literature safety surveillance for marketed and investigational products. Assist with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review.
 Provide assistance in signal detection and analysis activities, ensuring that safety signals are appropriately managed and tracked.
 Interface with other functional groups within Lifecycle Safety and other business units, such as Regulatory Affairs, RWLP, Medical Writing, Clinical Research, Quality, and Information Technology, as needed.
 Participate in internal and external audits, as required.
 Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics.
 Read and acknowledge all necessary Quintiles standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented.

Job Requirements

 Working knowledge of Lifecycle Safety services and processes; willingness and aptitude to learn new skills across Lifecycle Safety service lines.
 Basic knowledge of applicable global, regional, local regulatory requirements; i.e. Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), and International Conference of Harmonization (ICH) guidelines, Standard Operating procedures (SOPs)
 Ability to meet strict deadlines; manage competing priorities and ability to be flexible and receptive to changing demands.
 Sound organization and time management skills.
 Ability to follow instructions/guidelines, work independently and on own initiative.
 Good attention to detail and accuracy and maintain high quality standards.
 Effective written and verbal communication skills.
 Sound judgment; independent thinking and decision making skills.
 Ability to establish and maintain effective working relationships with coworkers, managers and clients.
 Ability to mentor effectively to less experienced team members.
 High School Diploma or educational equivalent and minimum 2 years’ experience of drug safety or minimum of 3 years safety scientist coordinator experience or equivalent combination of education, training and experience
EEO Minorities/Females/Protected Veterans/Disabled

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes.

Whatever your career goals, we are here to ensure you get there!

We invite you to join IQVIA™.

Job ID: R1050138