IMS Health and Quintiles have come together to be IQVIA
. We have created a new way to harness advances in technology, analytics and human ingenuity called Human Data Science, to deliver solutions that help our customers drive healthcare forward and help patients around the globe. Inspired by the industry we help, our employees are committed to providing solutions that enable life sciences companies to innovate with confidence, maximize their opportunities and ultimately drive human health outcomes forward.DescriptionRESPONSIBILITIES
• 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.
• 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 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 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. Job Requirements
- 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.
- 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.
Meaningful results require not only the right approach but also the right people
. Regardless of your role, we invite you to reimage healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and help patients around the globe. Whatever your career goals, we're here to confidently get you there!