Mohd Shahnawaz Khan Email and Phone Number

CBM associate,Retro QC of cases in ArgusCAPA evaluation activity in Quadrant,FSD, BRD, User guide monitoring, and wireframe of PV tools.Dashboard Preparation in SpotfirePPD call quality

• Other duties as assigned by management.• Experience in case processing of literature cases, spontaneous cases, clinical trials, pregnancy cases, business partner cases, regulatory authority cases, litigation cases, device cases, and cases with product quality complaints.• Assignment of cases within the team and to check the status at EOD.• To check Compliance and LMS training status of the employees within the team.

• Maintain awareness of changes to/new regulations affecting PVG activities.• Execution of company Standard Operating Procedures.• Builds and maintains good relationships across functional units and company affiliates.• Compliance with project guidelines.• Trains and mentor's new employees in PVG.• To carry out the necessary administrative duties required for the job

• Final Quality review of the information captured in Safety database as per Source document.• Completion of case processing which includes duplicate check, data entry, labeling, manual coding, narrative writing, queries, and quality review of cases.• Review of literature articles and assessment for identifying valid ICSRs (if applicable).

• Intake in Argus database.• Triage of incoming cases to determine seriousness and minimum requirement of Individual Case Safety Report for prioritization of daily workflow.• Data entry of the Source document in Safety database (ARGUS).• Assessment of ICSRs in pharmacovigilance database.