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Manager Pharmacovigilance

12.00 to 15.00 Years   Pune   08 Mar, 2020
Spectrum Talent Management
Job LocationPune
EducationNot Mentioned
SalaryNot Disclosed
IndustryManagement Consulting / Strategy
Functional AreaSales / BD
EmploymentTypeFull-time

Job Description

Roles and Responsibility :

  • Roles and Responsibilities:
Liaising with the client for coordination of case processing and related activitiesRole involves people management client delivery and meeting quality and process metrics for ICSR and aggregate reporting.Contributing to resource planning, work capacities and managing the workload Handling a team of pharmacovigilance experts into case processing creating adverse event reports.Work in a matrix environment to oversee and supervise employees working on deliverables for the assigned clients, including case processing, medical review, and safety reporting.Generate metrics and status reports for clients and monitor upcoming deliverablesUndertake Root Cause Analysis (RCA) and formulate Corrective And Preventative Actions (CAPAs) if issue ariseMeeting SLAs maintain productivity and handling escalations are some of the KRAs associated with this role.Maintaining an excellent knowledge of clients procedures, conventions, guidelines and international drug safety regulationsProviding training to team members on an ongoing basis, and when processes/procedures are updated, or when new procedures are introducedSPOC for pharmacovigilance assigned full - service projects.Oversee implementation of projects including client communications, project specific plans, system set - up, and establishment of appropriate and agreed - upon metrics and ensure the assigned project contracted tasks are completed according to project specific procedures and key metricsComplete all departmental project activities accurately and in accordance with SOPs, Project Specific Procedures, regulatory requirements, and Sponsors processes.Completion of project status reports/review meetings including burn hours, profit margins, quality review findings and other metrics.Lead identification of out of scope activities and process efficiency/improvement needs or implement contract amendments/change orders as requiredCoordinate and present at meetings (project and department) as requiredSupport QPPV as requiredParticipate in process improvement by actively identifying process improvements, developing better procedures, and working to additionally implement those change / process improvementsInterview, evaluate and recommend new PVSafety Systems hiresCoordination and participation in interdepartmental activities,

Keyskills :
providingtraining clientdelivery clinicalresearch keymetrics peoplemanagement processimprovement rootcause stakeholdermanagement slas root resourceplanning rootcauseanalysis caseprocessing regulatoryrequirements set profitmargins medicalre

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