Abhilash Rachakatla
Deputy Manager (Medical Information Operations) @Cipla
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WORK HISTORY
Deputy Manager (Medical Information Operations) @Cipla
Mumbai, IN
To oversee the day-to-day governance and management of operations and compliance for PV MICC activity including the MICC (service provider) activities.• To perform monthly quality review of cases from MICC service provider for accuracy, quality and overall consistency.• To ensure proper governance and management for Global MICC operation.• Ensure all MICC related documents are prepared. Managed and archived appropriately.• Provide feedback for improvement and track performance of MICC vendor.• Implement and support MICC set-up as per Global PV plan requirement.• To support and ensure and monthly testing is conducted for PV Toll free numbers.• To identify areas of improvement in terms of compliance, quality, and productivity• To monitor and ensure SLA performance of service providers; and escalate challenges and disuse with stakeholders in a timely manner• Preparation, Management and Archival of Vendor documentation to ensure compliance to processes.• To perform investigation, RCA, CAPA in TrackWise.• To prepare, review or update relevant SOPs or project documents• To identify areas of improvement in terms of compliance, quality, and productivity, and support in implementation of action items.• To support during Internal Audits and Inspections.• To function as a trainer for assigned trainings for internal/external stake holders.
ABOUT ABHILASH RACHAKATLA
As a Drug safety associate.• Initial data entry of case reports and narrative typing as per the exact verbatim of the callers which were US based HCP’s, Non-HCP’s and Clinical investigators. • Case management and call distinguished as an AE, Non-AE, Medical Inquiry and Product Complaint. • Data entry individual cases safety reports in Argus Safety Database. • Coding of Adverse Events/PQC. • Inconsistency check to prevent reverts. • Reconciliation. • Triage.
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