Uma Maheswar Reddy Gopalu

· Performance Monitoring: Monitor vendor performance through key performance indicators (KPIs) such as delivery times, quality of goods/services, and cost-effectiveness.

· Handling Global Drug Safety and Literature email box

· Training Vendor employes and certified as applicable

· Internal and external reconciliation as applicable in SDEAs

· Review and approving Nullification requests, SUSAR cases and other ad-hoc requests (case corrections etc).

· Managing case processing and Literature trackers and updating metrics.

· Order and provide FTAs as required.

• Lead and manage the projects to comply with SoWs and SLAs
• Monitors quality of work and efficiency of team members with contracted scope of work and safety management plan.
• Work with finance to ensure appropriate customer invoicing where required.
• Record, maintain and track metrics for both team members and project performance.
• Creation of dashboards and presentation of the team members performance in the monthly process leads meeting.
• Ensure that RMPs align with the product’s lifecycle, from pre-marketing through post-marketing surveillance.
• Prepare and Review risk management plan (RMP) and any other ad-hoc reports requested by client.
• Planning and implementation of risk minimization measures, including the evaluation of the effectiveness of these activities.
• Facilitate and conduct safety review meeting as and when required and liaise with the risk minimization physician on new RMP request or update to existing RMP based on health authority request, update the safety profile or any other reason.
• Initiate, organize and lead the Call for Information (CFI) meeting/ Kick off meeting (KOM), or any other necessary ad-hoc meetings with agreed contributors.
• Prepare meeting minutes and distribute final meetings with all invitees and archive the communications into agreed client repository.
• Ensure that the RMP addresses real-world data, post-marketing adverse events, and the effectiveness of risk minimization activities.
• Ensure RMPs and associated documents are prepared and submitted in accordance with regional regulatory agencies’ requirements, such as EMA (European Medicines Agency), FDA, and others.

• Authoring and review of EU risk management plans (RMP) and Non-EU RMPs for assigned reports.
• Monitor and review of trackers (RMP/RMM/PASS) and / or logs to be filled as per the standard operating procedures.
• Support coordination with relevant stakeholders to ensure information received, analyzed and incorporated into Aggregate Reports as per the regulatory requirements.
• Retrieve and analyse the safety data from global safety database and ensure adequate presentation in Aggregate Reports.
• Ensure compliance related to periodic reports (procedures, quality, timelines, regulations, consistency).
• Responsible for ad-hoc requests received from Health Authorities.
• Request client/external stakeholders to provide inputs for the report.
• Focus on the risk management activities in the post-marketing phase in line with GVP Module V, which emphasizes the ongoing assessment of risks associated with marketed drugs.

• Preparation of monthly assignment spreadsheet from TrackWise and counting of 15-day cases: The task involves pulling data from TrackWise to create a summary of PADERs to be prepared within the month.
• Preparation of periodic safety reports, PADERs, for the USA regulatory agency (FDA).
• Performs quality control of PADERs: it’s crucial to perform quality control checks to ensure its Accuracy, Compliance, Consistency and Completeness.
• Submitter, Writer, and QC role in the TrackWise system.
• Generate line listings for the respective reports from safety database.
• Working with different stakeholders with respect to the PRAC recommendations and labelling changes to include in the PADERs.
• Working with signal management team on monthly basis to capture the information accurately in the PADERs.

• Process lead for six monthly and Argus line listings (for aggregate reports).
• Creation of process maps and SOPs required for the process.
• Responsible for tracking compliance, and creating of deviations in the project.
• Conduct literature safety surveillance for marketed and investigational products.
• Assist with identifications of ICRSs from literature, evaluation of events with special interests as well as aggregate data review.
• Provide assistance in signal detection and analysis activities, ensuring that signals were appropriately managed and tracked.
• Participate in the internal and external audit as required.
• Perform daily work in conjunction with Line Manager for aggregate reports generation and any other tasks relevant to Pharmacovigilance department.
• Responsible for tracking and completion of the Argus reports.

• Prioritize incoming AEs/SAEs and ERs information for further processing and confirm receipt as required.
• Collect, review, and assess adverse event (AE) reports, including serious adverse events (SAEs) and adverse drug reactions (ADRs) for spontaneous and clinical trails cases associated with medicinal products and devices.
• Case Evaluation: Assess and evaluate the seriousness, causality, and outcome of reported adverse events in compliance with regulatory guidelines.
• Narrative Writing: Prepare clear and concise narratives for reported cases, detailing the adverse event description, patient information, and outcomes.
• Case Follow-Up: Manage the follow-up process for incomplete or unclear cases by liaising with healthcare professionals, patients, and other relevant parties to gather missing information.
• Regulatory Compliance: Ensure adherence to local and global pharmacovigilance regulations, ensuring that reports meet the required quality and compliance standards.
• Reconciles SAEs in accordance with project specific guidelines.

• Case Intake and Receipt: Gather information on adverse events reported by healthcare professionals, patients, or other sources (clinical trials, literature, or regulatory bodies).
• Identify the source of the adverse event report. This could be a healthcare professional (HCP), a clinical trial, a literature search, a patient self-report, or regulatory bodies.
• Data Entry into Pharmacovigilance Database: Enter the adverse event information into the pharmacovigilance system (e.g., Argus, ARISg) according to the regulatory format (e.g., CIOMS, MedDRA coding).
• Use standardized terms to ensure consistency in reporting and analysis.
• Ensure accuracy of information related to patient details, the nature of the event, the medical condition, and the suspected drug.
• MedDRA Coding: Code the medical information (such as adverse events, drugs, medical history) using the MedDRA (Medical Dictionary for Regulatory Activities) terminology.
• This is necessary for classifying adverse events, therapeutic indications, and outcomes.
• Case Assessment and Evaluation: Evaluate the potential causal relationship between the adverse event and the drug(s) involved.
• This assessment may involve the use of standard causality algorithms (e.g., WHO-UMC, Naranjo scale).
• Review the timing of the event in relation to drug administration.
• Consider patient medical history and other potential confounding factors.
• Perform consistent coding of diseases, adverse events and medications according to the project specific guidelines.
• Reconciliations of SAEs in according with project specific guidelines.

• Oversee the collection, validation, and management of clinical trial data from multiple sources, ensuring the accuracy and integrity of clinical research data.
• Coordinate with clinical research teams, investigators, and external vendors to ensure timely and accurate data collection.
• Review, validate, and reconcile clinical trial data, including addressing discrepancies and ensuring data is complete and consistent.
• Collaborate with statistical teams to ensure data is formatted for analysis and complies with protocol requirements.
• Support audits and inspections, ensuring documentation is accurate and data is compliant with industry regulations.
• Work closely with Medi data Rave and Clinical developers on the design, testing and implementation of study databases.