ROHITH GARIMILLA

· Responsible for global compliance, quality, efficiency and management of post marketing & clinical trial safety cases for products across Sandoz Group Portfolio.

· Ensure development and maintenance of processes for in-house and outsourced activities related to Safety Case management in collaboration to meet Safety case reporting regulatory requirements. Author, review and update SOPs related to Safety case management.

· Interact with strategic supplier to review their performance and identify areas of development for capability building

· Lead global internal audits and Health Authority Inspections taking complete responsibility for inspection readiness and timely implementation of necessary corrective and preventive actions.

· Lead case management related workstreams and act as subject matter expert for cross functional projects including strategic Novartis acquisitions and mergers

· Represent Patient Safety at internal and external meetings with global line-functions and third party (eg. Vigilance Agreement Partners)

· Drive operational excellence to optimize business efficiency in alignment with Patient Safety’s objectives and vision

· Responsible for assuring conformity with global procedures, process, and regulatory requirements for all associates of safety case management team within Sandoz and strategic suppliers.

· Lead recruitment, objective setting, and performance management of direct reporting associates.

· Setup and maintain training plans for new hires accordingly to job role and responsibility.

· Lead/support continuous improvement, quality, productivity, and innovation leveraging internal and external people, process and technology

· Contribute to talent retention strategy and development team members.

· Deputize for Head Case Management and Aggregate Reporting as needed.

• Serve as the Regional Group Lead for Medical Safety Writing team responsible for authoring safety-related regulatory documents.
• Handle budgeting, recruitment, annual performance reviews, appraisals and decision making on salaries.
• Monitor project timelines and resourcing needs across technology platforms.
• Ensure high-quality safety deliverables and provide guidance to Medical Safety Writers.
• Perform manager review of the safety deliverables and ensure accurate submission of the reports.
• Oversee coordination with cross-functional subject matter experts to author postmarket surveillance plans.
• Support audit/inspection questions regarding Medical Safety Writing processes.
• Establish and maintain working relationships with global and local Alcon functions to ensure the fulfillment of safety-related regulatory requirements.
• May function as delegate to manage additional countries according to regulatory or business needs.
• Global Medical Safety team – Medical Devices

• Lead preparation of various Aggregate Safety Reports (ARs) for global regulatory submissions including Periodic Safety Update Reports – PSUR.
• Post Market Surveillance Plans – PMSPs, Benefit Risk Assessments – BRA, and Global reports for medical devices.
• Coordination with Global Line functions – GLFs to ensure information received, analyzed and incorporated into ARs as per the regulatory requirements.
• Retrieve and analyze the safety data from global safety database and ensure adequate presentation in the ARs.
• Ensure a comprehensive and consistent aggregate analysis performed to establish the risk benefit profile of the product that meets all HA requirements.
• Support independent QC of ARs to ensure the information presented in AR is complete, consistent and compliant to regulatory and organizational standards.
• Adhere to good documentation practices to ensure audit/inspection readiness.
• Global Medical Safety team – Medical Devices

• Lead preparation of various Aggregate Safety Reports (ARs) for global regulatory submissions including Periodic Benefit Risk Evaluation Reports – PBRERs, and Periodic Adverse Drug Experience Reports – PADER for Pharmaceuticals and medical devices.
• Coordination with Global Line functions – GLFs to ensure information received, analyzed and incorporated into ARs as per the regulatory requirements.
• Retrieve and analyze the safety data from global safety database and ensure adequate presentation in the ARs.
• Ensure a comprehensive and consistent aggregate analysis performed to establish the risk benefit profile of the product that meets all HA requirements.
• Supporting the signal management activity in presentation of validated signals in applicable section of the PSURs.
• Alert the Medical safety physicians of potential safety issues and assist the Medical safety physicians in monitoring the safety profile of products.
• Support independent QC of ARs to ensure the information presented in AR is complete, consistent and compliant to regulatory and Novartis standards.
• Vendor management activities including monthly KPI parameters tracking, preparation and presentation of monthly AR operations data and PSUR publishing co-ordination activities with clinical publishing team.
• Safety writing team – Pharmaceuticals

• Handling a team of 25 newly joined and experienced associates.
• Allocation of reports to the authors, QC associates and medical reviewers based on the data lock point of the reports shared by the client.
• Tracking the progress of the reports at each activity and making sure all the reports are completed at each activity and the same has been shared for client review within the timelines.
• Performing various operational activities such as tracking, maintenance of metrics, quality checks and trainings for the newly joined associates.
• Liaise with client and acts as primary point of contact for all report writing and submission related activities.
• Responsible for authoring various safety reports for global regulatory submissions which includes Periodic Benefit Risk Evaluation Reports – PBRERs, Periodic Safety Update Reports – PSURs, and Periodic Adverse Drug Experience Reports – PADER.
• Performing QC for the reports authored by the safety writers and to make sure that all the reports are drafted as per the client expectations.
• Internal & External communication to get the required inputs while drafting/QC of the reports.

• Work allocation and tracking all the reports on a daily basis.
• Allocation of reports to the authors, QC associates and medical reviewers based on the data lock point of the reports shared by the client.
• Responsible for authoring various safety reports for global regulatory submissions which includes Periodic Benefit Risk Evaluation Reports – PBRERs, Periodic Safety Update Reports – PSUR and Periodic Adverse Drug Experience Reports – PADER.
• Prioritization of all the regulatory and internal due cases on a daily basis and making sure that all the cases are submitted within the timelines with excellent quality.
• Conducting trainings for all the newly joined associates in the team and involving in their certification process before they come into production.
• Handling submissions team and making sure all the cases are submitted on time for the regulatory authorities for which the global submissions team is responsible.
• Handling all the rejections and making sure that necessary corrections are done for the respective cases by bringing them into data clean up activity. Post corrections, cases will be redistributed to the authorities for which they got rejected.
• Updating the RRM sheet biannually as per the new requirements of the regulatory authorities by contacting the local safety officers.
• Preparing and updating the work instruction documents and SOPs for Data entry & Quality review, Distribution and Submissions as per the latest updates shared by the client.
• Turn Around Time – TAT calculation for the entire project and sharing the data with the client on weekly and monthly basis.

• Triage, case processing, quality review, distribution and submission of Individual Case Safety Reports – ICSR.
• Knowledge in Drug Safety Databases- ARISg – Versions 6.2.3 and 7.2.3.
• Responsible for case duplicate check and maintain log of source documents and other communications for the case.
• Evaluates adverse event reports, assesses regulatory status which is seriousness, expectedness, relatedness in order to prioritize workload.
• Initial receipt of cases database searches as necessary. Registry and triage of incoming cases to determine seriousness, expectedness and causality for prioritization of daily workflow.
• Completion of case processing activities including case data entry, labelling, action taken, de-challenge and re-challenge.
• Event coding as per MedDRA latest versions.
• Full case narrative writing for spontaneous and study reports.
• Clarification of unclear or illegible information from the local safety officer or call center as per the project requirement.
• Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields.
• Responsible for coding all medical history, events, drugs/procedures/indication and lab tests according to appropriate dictionary – MedDRA, WHO–DD and writing case narratives.
• Labelling of adverse events according to the drug specific labelling documents.

• Triage, case processing and quality review of Individual Case Safety Reports – ICSR.
• Knowledge in Drug Safety Database SCEPTRE.
• Responsible for case duplicate check and maintain log of source documents and other communications for the case.
• Evaluates adverse event reports, assesses regulatory status which is seriousness, expectedness, relatedness in order to prioritize workload.
• Initial receipt of cases database searches as necessary. Registry and triage of incoming cases to determine seriousness, expectedness and causality for prioritization of daily workflow.
• Completion of case processing activities including case data entry, labelling, action taken, de-challenge and re-challenge.
• Event coding as per MedDRA latest versions.
• Full case narrative writing for spontaneous and study reports.
• Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields.
• Responsible for coding all medical history, events, drugs/procedures/indication and lab tests according to appropriate dictionary – MedDRA, WHO–DD and writing case narratives.