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Safety Aggreg Report Spec 2 (R1028230) in Shanghai, China at IQVIA™

Date Posted: 3/28/2019

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Job Description


Apply knowledge and expertise for Safety Aggregate Report and Analytics (SARA) Center deliverables including safety aggregate reports, literature surveillance, signal management activities and benefit risk management documents.


 Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements.

 Lead, author and finalize aggregate reports, including but not limited to PBRERs, DSURs, PADERs, RMPs, ACOs, and six monthly line listings; author responses to regulatory agency/PRAC inquiries, as required.

 Conduct/Lead 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.

 Conduct/Lead 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, acknowledge and adhere to all necessary Quintiles standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented.

 Serve as the interface between the global project lead and the working team; conduct regular lessons learned with the working teams to ensure all information from the customer is cascaded to the relevant team members.

 Provide mentorship and training to less experienced resources.

 Provide regular reports to overall project manager and department management on project metrics, SOW changes, client requests or concerns; participate in project review meetings with management; communicate and document project issues to project team members and department management in a timely manner.


 Excellent knowledge of Lifecycle Safety services and processes; willingness and aptitude to learn new skills across Lifecycle Safety service lines.

 In depth knowledge and understanding of applicable global, regional, local regulatory requirements; i.e. Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and International Conference of Harmonization (ICH) guidelines, SOPs.

 Proven ability to meet strict deadlines; manage competing priorities and ability to be flexible and receptive to changing demands.

 Excellent organizational skills and time management skills.

 Proven ability to follow instructions/guidelines, work independently and on own initiative.

 Excellent attention to detail and accuracy maintaining consistently high quality standards.

 Excellent written/verbal communication and report writing skills.

 Sound judgment; independent thinking and decision making skills.

 Ability to establish and maintain effective working relationships with coworkers, managers and clients.

 Effective mentoring and coaching skills.

 Good understanding of operational metrics, productivity and initiatives.

 Demonstrate effective project management and leadership skills.

Job ID: R1028230

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