SINDHURA KOYYALAMUDI

Senior Safety specialist

• Performing Case Intake/Case initiation, Triage, Data entry and Quality assessment of ICSRs
• Trained new associates in all case processing aspects
• Review patient information in the database and ensure accurate documentation as per client needs
• Attach Post Infusion Reports to databases to ensure proper documentation for patient assistance and drug safety program needs
• Conduct causality assessments for safety cases reports
• Receive, scan and document all pertinent clinical information in compliance with SOP/protocol and applicable legislation
• Worked directly with external clients to request additional information or clarification as necessary
• MedDRA coding assessment
• Perform expectedness and listedness assessment and ICSR reportability
• Contribute to submissions of ICSRs when required
• Assist in the preparation, review and evaluation of signals, aggregate reports, and risk management plans
• Contribute in generating responses to regulatory authority requests on product safety related issues for marketed products or product in development.

Medical writer

• Provided quality project management with internal team members, CROS, and key decision makers in clinical programs.
• Successfully prepared strategic submission documents: (e.g. INDs, NDA molecules, clinical study reports, protocols, protocol amendments and, clinical summaries/narratives).
• Coordinate quality control reviews of those documents and maintain audit trails of changes.
• Interact closely with sponsor, and other medical subject matter experts.
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• Patient counseling for all the employees
• Documentation of employees past and present medical history
• Instigate changes in working practice
• Maintain records
• Carry out in-house training for employees and managers
• Offer advice on issues like fire regulations, hazardous substances, and occupational diseases.

• Receive, scan and document all pertinent clinical information in compliance with SOP/protocol and applicable legislation
• Worked directly with external clients to request additional information or clarification as necessary
• Review patient information in database and ensure accurate documentation as per client needs
• Attach Post Infusion Reports to databases to ensure proper documentation for patient assistance and drug safety program needs
• Conduct causality assessments for safety cases reports
• MedDRA coding assessment
• Perform expectedness and listedness assessment and ICSR reportability
• Contribute to submissions of ICSRs when required
• Assist in the preparation, review and evaluation of signals, aggregate reports and risk management plans
• Contributed in generating responses to regulatory authority requests on product safety related issues for marketed products or product in development.

• Worked for 12 months in M.S
• Ramaiah Teaching Hospital as Pharm.D intern and performing clinical pharmacist duties in various departments General medicine Surgery Dermatology Pediatrics
• Responsibilities included attending ward rounds, critical analysis of prescriptions, patient history interview, patient counseling, providing drug information, monitoring adverse drug reactions & drug interactions.