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 in project execution, ensuring that strategic decision is implemented effectively and efficiently.
• Responsible for the planning, coordination, and management of Safety Leads to accomplish project assignments to the highest quality standards within the given deadlines. 
• Support Precision leadership in strategic planning  
• Other duties as assigned.

Qualifications: 

Minimum Required: 

• Bachelor’s degree or higher in Health/Biomedical Sciences related field or other relevant educational training 
• Clinical Trial experience  
• Possess knowledge of the Global Patient safety database for end-to-end IT service delivery starting from strategy formulation to execution.
• Proficient analytical skills and technical and project management expertise supporting safety surveillance activities, signal detection, benefit-risk assessment, and Safety studies.
• Experience in safety reporting applications is required. Knowledge of OBIEE is preferred.
• Relational database knowledge working with Oracle and SQL is required.
• Good general knowledge about the global safety reporting requirements and ICH E2B guidelines that govern the global reporting of adverse events on investigational and marketed products are preferred.

Other Required: 

• Minimum of 5-7 years of experience in safety in the CRO or pharmaceutical industry 
• At least 2-3 years of people management experience
• Solid knowledge of FDA safety regulations, ICH Guidelines, and other applicable regulatory guidance documents; working knowledge of global safety regulations. 
• Experience with case processing in ARGUS 
• Proven experience and success as an analytical thinker with proficiency working with other data analysis platforms.
• Proven ability to understand and execute projects by prioritizing, planning with appropriate relevant individuals, remaining transparent, well organized and ensures time management efficiency until project completion.
• Demonstrates excellent oral, written communication and analytical skills, is attentive to details and timelines.
• Must be flexible and this position may require working outside of regular hours to accommodate business needs, ensuring timely and effective delivery of objectives.
• Ability to effectively adapt to a variety of situations. 
• Strong influencing skills  
• Excellent communication skills, both written and oral 
• Work effectively as a team member and promotes collaboration 
• Demonstrate ownership, initiative and accountability 
• Supervisory experience 
• Proven writing skills and excellent communication skills. 
• Proven oral presentation skills. 
• Less than 20% travel.  

Competencies:  

• Ability to deliver on commitments and understanding of service culture 
• Communicates effectively and efficiently on safety issues to internal and external stakeholders. 
• Maintain consistency of safety assessments. 
• Serve in cross-functional teams as Drug Safety expert. 
• Monitor regulatory compliance of safety deliverables throughout trial. 
• Lead or contribute to process development and/or process improvements that support Drug Safety

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