IQVIA Safety Aggregate Reporting Manager (Home-based) in Overland Park, Kansas
- Act as a stand-alone global functional lead at a project level applying experience, knowledge and expertise for Safety Aggregate Report and Analytics (SARA) Center deliverables including but not limited to safety aggregate reports, literature surveillance, signal management activities and benefit risk management documents. Actively contribute to Lifecycle Safety global process initiatives and work in close collaboration with the safety customer delivery management team regarding project/client initiatives. Ensure team is following standard best-in-class practices established by the SARA infrastructure.
Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements.
May serve as a stand-alone global lead for aggregate reporting, signal management, or literature surveillance projects.
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.
Perform quality checks of assigned SARA deliverables, and complete relevant QC checklists/trackers
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. Lead audit preparation activities in advance to audit and ensure audit readiness of project
Review project files and contact lists on a regular basis to ensure compliance with SOPs
Lead functional team and contribute to achievement of departmental goals e.g. utilization realization and productivity metrics.
Read and acknowledge all necessary IQVIA 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 learnt 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.
Manage resource needs and resource allocation based on workload to ensure appropriate compliance with report submissions.
Build a positive, collaborative team environment with SARA team members, lead by example and provide training and mentoring for less experienced team members.
Contribute and assist in global/local working groups as applicable in implementation of new operational initiatives, identification and implementation of process efficiencies.
Participate in the authoring and review of standard operating procedures (SOPs).
Proactively identify issues and proposed solutions.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
In-depth knowledge of Lifecycle Safety processes, audit practices, governing safety legislation/regulation; willingness to increase knowledge across Lifecycle Safety service lines and develop new skills.
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 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.
Strong project management, leadership, and mentoring skills.
Strong presentation and customer focused skills.
Ability to encourage a flexible and receptive approach to changing demands and proven ability in the implementation of new initiatives.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Bachelor’s Degree or educational equivalent in a Scientific or Healthcare discipline and at least 5 years’ of drug safety or 3-5 years’ experience in aggregate reporting or equivalent combination of education, training and experience.
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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IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at firstname.lastname@example.org to arrange for such an accommodation.
At IQVIA, we have a vision. Where every healthcare decision is based on evidence. Where data science and human science come together to improve global health. Where new and creative solutions aren’t just possible – they are expected.
Thank you for your interest in growing your career with us. It takes insight, curiosity, and intellectual courage to transform healthcare. The 56,000+ employees of the IQVIA family of companies, including Q2 Solutions, are reimagining a world without the consequences of disease. We are brave minds bringing powerful ideas to reality. At IQVIA, you can truly make an impact in an environment where you’re supported to succeed.