Direct and provide line management for global assigned Safety Aggregate Reporting and Analytics (SARA) staff responsible for signal detection and benefit risk management services. Actively contribute to Lifecycle Safety global process initiatives and work in close collaboration with the safety customer delivery management team regarding project/client initiatives and driving revenue growth. Ensure team is following standard best-in-class practices established by Safety Aggregate Reporting and Analytics (SARA) infrastructure.
Line manager of staff, based at one or more sites. Responsible for performance of direct reports (quality, profitability, utilization). Responsibilities include planning, assigning and directing work; appraising performance and guiding professional development; rewarding and disciplining employees, addressing employee relations issues and resolving problems. Approve actions as applicable on human resources matters.
Works with senior management to understand and interpret Business Unit strategy and effectively communicate and implement across direct line reports.
Assist SARA management with bid defense/proposal development for SARA center opportunities.
Keeps abreast of current data, trends, SARA/regulatory knowledge, developments and advances in area of aggregate reporting, literature surveillance, signal management, and drug development.
Lead team and ensure achievement of departmental goals e.g. utilization realization and productivity metrics.
Manage resource needs and resource allocation based on workload to ensure appropriate compliance with project and regulatory requirements.
Build a positive, collaborative team environment with SARA team members, lead by example and provide training and mentoring for local project leads and less experienced team members.
Serve as a stand-alone global lead for full service projects and act as a single point of contact from Safety Aggregate Reporting and Analytics (SARA) for all SARA deliverables
Serve as a global lead for aggregate reporting, signal management, or literature surveillance projects.
May lead, author and finalize complex aggregate reports, including but not limited to PBRERs, DSURs, PADERs, RMPs, ACOs, and six monthly line listings; author responses to regulatory agency/PRAC enquiries, 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. Identify potential signals and validate. Contribute to analyses in external databases using data mining methods for detection and evaluation of safety signals. Assist in aggregate safety data review and preparation of signal assessment reports.
Perform quality check of all assigned SARA deliverables, and complete relevant QC checklists/trackers. Perform analysis of quality check results and identify training needs; train staff as appropriate.
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.
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 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.
Contribute and assist in global/local working groups as applicable in implementation of new operational initiatives, identification and implementation of process efficiencies.
Author, approve or participate in the review of SARA or cross-functional standard operating procedures (SOPs).
Proactively identify issues and proposed solutions.
Provide consultative guidance to internal and external stakeholders for all SARA deliverables.
Suggest, drive, and implement continuous process improvements across all SARA center services.
Collaborate with line managers to resolve project performance related issues of staff.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Excellent team leadership and customer service skills; strategic customer focus.
Extensive knowledge of Lifecycle Safety processes, audit practices, governing safety legislation/regulation; willingness to increase knowledge across One Q Safety service lines and develop new skills.
Extensive 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, SOPs.
Highly effective time management and delegation skills, ability to manage multiple competing priorities, meet multiple demanding timelines and work creatively in fast-paced environment.
Excellent attention to detail and accuracy maintaining consistently high quality standards.
Excellent written/verbal communication and report writing skills.
Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Excellent understanding of operational metrics, productivity and initiatives.
Excellent project management, leadership, and mentoring skills.
Excellent presentation and customer-focused skills.
Excellent judgment, decision-making and problem solving skills.
Encourage a flexible and receptive approach to changing demands and proven ability in the implementation of new initiatives.
Self-motivated driven and ability to work autonomously.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor's degree or educational equivalent in health science or other directly related field and 10 years' experience in drug safety or minimum 8-10 years in aggregate reporting or equivalent combination of education, training or experience and at least 6-8 years management experience.
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