Manager, PV Systems and Projects

Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. Our novel approach integrates clinical operations excellence, with laboratory expertise, and advanced data sciences to inform every step. We apply our expertise to trials at all stages—from early development through approval—with embedded experience in oncology and rare disease. With over 2000 dedicated professionals and 35 offices worldwide, we stand ready to help accelerate life-changing treatments anywhere around the globe. Won’t you join us today as a Manager, PV Systems and Projects?

Position Summary: 

Responsible for oversight of Drug Safety Leads including oversight of new studies with Safety component or Safety standalones. Responsible for leading Precision Safety’s project team to deliver contracted services and ensure achievement of contracted project milestones for assigned Safety projects. The Manager, PV Systems and Projects will have oversight of the Argus vendor, management and maintenance of SOPs, and the development of project specific plans and responsible for Argus migration and configurations associated with clinical trials and/or post-marketing safety surveillance. 

Essential functions of the job include but are not limited to:  

• Responsible for the day-to-day management of Drug Safety Leads and execution of Safety projects
• Prepare and/or review and approve project specific Safety Management Plans  
• Prepare and/or review of safety training materials as it relates to Safety projects and PV systems.
• Manages Pharmacovigilance project(s) as assigned per the scope of work and within the contracted budget and timelines.
• Oversees all aspects of the PV project conduct from Start-up through Close-Out.
• Responsible for on-time and on-budget delivery of the project
• Participate in the coaching and development of direct reports by providing an environment that encourages ongoing personal and professional development. 
• Maintains expertise in PV concepts and the safety systems landscape to support processes starting from AE/PC and inquiry intake to submissions, Periodic Reporting for Safety and Risk Assessment as applicable, System Upgrades, Data Migrations and Divestitures, Product Integration, Reporting distribution rules and other related data system activities.
• Leads and coordinates internal project and client teleconferences/meetings.
• Prepares project timelines and project management related deliverables.
• Identity, document, track and resolve project action items for multiple programs simultaneously.
• Provide support to Global Patient Safety Systems, PV Operations, Safety Physician, and Medical Monitors
• Support the Global Patient Safety Systems to maintain and update the Safety Systems per global regulations and as needed for process streamlining and improvement.
• Represent and collaborate with the internal and external business users, IT, QA, and vendors, supporting the evaluation of the safety database and associated reporting and signaling tools.
• Serve as a system administrator and perform configurations/master data updates like code lists, user access, reporting rules, products, and studies.
• Perform quality checks on Safety System configuration changes performed by the database service provider; identify discrepancies between the request and the implementation and resolve or initiate resolution.
• Participate in the process of qualification/validation of global safety database applications.
• Support the generation of formal reports, summaries, and listings supporting safety monitoring, signal detection, and aggregate reporting deliverables (PBRER, DSUR) in conjunction with the database service provider.
• Provide support to global end-users and ensure understanding of their needs.
• Author/support system related Standard Operating Procedures (SOPs)/Working Instructions (WIs)
• Serve as subject matter expert (SME) for audits and inspections as needed.
• Develops and implements Corrective and Preventive Actions (CAPAs) related to Safety study management issues as necessary.
• Tracks non-compliance issues occurring in the frame of all Safety studies/ projects.
• Perform other safety system related activities, as needed, or as requested by Safety management.
• Debug complex IT problems in partnership with IT and/or system vendor(s) where applicable.
• Maintain intelligence of current global regulations/guidelines for governance in reporting of pre-approved (investigational) and approved (post-marketing) events to advise on safety system design and configuration.
• Takes a 100% hands-on approach