SOWMYA Manjanna

• Leading a team of 400+ Associates across 5 direct Manager reports.
• Collaborate with cross functional teams like Medical review, Submissions, regulatory reporting, support desk and quality assurance teams to ensure on time quality delivery to meet customer commitments.
• Monitoring invoice and work order of the project.
• Backlog grooming, estimating effort and plan for the new projects.
• Monitor any out of scope activity on monthly basis and follow up on the change order execution.
• Provide suggestion on new business opportunity/ process efficiencies with existing client.
• Identify potential gaps in process/system impacting regulatory or SLA metrics and proactively collaborate with customers to resolve them.
• Measure and publish contractual SLAs/ KPIs monthly to the project team and stakeholders (Quality, productivity and other performance dashboard).
• Ensure to meet the Quality and Compliance targets as defined in the Project KPIs and SLAs, and as per project expectations.
• Ensure Employee engagement activities are conducted in timely manner.
• Create roadmap on innovation and action plan to support it.

• Managed a team of 60 Associates with 4 direct reports.
• Monitored and reported monthly variances between forecasted and actual case volumes to stakeholders.
• Tracked out-of-scope activities monthly and followed up on change order execution.
• Reviewed team utilization monthly and took corrective actions as needed (e.g., requested or provided support).
• Continuous Improvement Plan : Develop and execute effective communication plans for management meetings, skip calls, etc.
• Succession Planning
• Team Based Decision Making :Participate in high potential talent retention activities and follow through on actions.
• Responsible of Performance Management cycle of the direct line reportees.

Well versed in strategic planning, execution and managing work load activities

 Maintain an action Log for customer communication and escalations. Ensure to follow up and close the action items within the defined timelines.  Ensure timely review of ongoing CAPAs, completion and submission of evidences for CAPAs/ECs/QI in EDA/customer quality systems within defined timelines.  Accomplished excellent ability to liaison with client companies, regulatory agencies, ethics committee across various departments and other external agencies with a broad expertise related to understanding the principles and application of quality and regulatory compliance related to GPVP regulated activities  Managing a team of 17 Associates.

 Conduct Root Cause Analysis for the cases submitted late to Regulatory agency.

 Responsible of Performance Management cycle of the direct line reportees.

 Responsible for the performance appraisal of the reportees.

 Analysis of risk involved in the process.

 Mitigation of risks using available technological, human or organizational resources.

 Work closely with the project support office in implementation of quality action plans to the team.

 Monitoring and controlling the Inventory at the optimum level for smooth function of operations.

 Improve operations output through optimization of resources, capacity utilization and escalate operational

Supervise Pharmacovigilance staff in accordance with organization’s policies and applicable regulations.  Managing a team of 20 Associates.  Planning, assigning and directing work with appropriate prioritization of work at registry, case processing and qualityreview workflow steps.  Assure timely movement of project work through the process steps, in accordance with governing SOPs, regulations and client expectations.  Work forecasting based on product transitions and resource management.

 Track and monitor any deviations and CAPA for individual case safety receipt system.

 Assist with meeting department realization targets.

 Daily Interaction with client in order achieve company expectations and compliance with the process. Process improvements to improve productivity and quality of the team

 Monitoring and controlling the Inventory at the optimum level for smooth function of operations.

 Improve operations output through optimization of resources, capacity utilization and escalate operational efficiencies.

 Proficient in developing and improving processes to stabilize quality by studying and implementing the product specific and process specific Standard Operating Procedures.

Streamline processes and plan capacities as per daily requisites.

 Co-ordinate with the processing team to develop plan, schedule and arrange resources and ensure achievement of pre-set targets as per goal pre-requisites.

 Follow procedures for supporting activities, such as preparing deviation memos.

 Understand safety implication regarding contracts with marketing partners

• Assessment of cases and processing accordingly.

• Assessment of weekly and monthly line listings.

• Perform edit checks- Review of labeling assessments based on line listings on a weekly and monthly basis.

• Review of case criteria to determine the appropriate workflow for case processing.

• Write and edit the case narratives appropriately.

• Generate reports, ensuring adherence to regulatory compliance timelines.

• Determine and perform appropriate case follow-up, generating and requesting follow-up letters.

• Subject Matter Expert (SME).

• Training and mentoring associates.

• Actively involved in resolving queries from clients, business partners and third parties.

• Triage, case processing and quality review.

• Identification of adverse event terms.

• Assessment of cases and processing accordingly.

• Review of case criteria to determine the appropriate workflow for case processing.

• Write and edit the case narratives appropriately.

• Generate reports, ensuring adherence to regulatory compliance timelines.

• Identification of event terms.

• Assessment of cases and processing accordingly.

• Review of case criteria to determine the appropriate workflow for case processing.

• Write and edit the case narratives appropriately.