Sushma Nentakala Venkateswarlu

Contributes to WWPS (Worldwide Patient Safety) inspections and audits, proactively regarding readiness preparation and post-evaluation, ensuring implementation of corrective and preventative actions within areas of expertise.

• Assists in managing the collection and assessment of global submission metrics of Individual Case Safety Reports (ICSRs) and Safety Aggregate Reports (SARs) to ensure compliance with proper regulations.
• Managed a team of 7+ employees by providing guidance, setting goals, and overseeing the day-to-day operations of global ICSR compliance for all late submissions.
• Ensuring all activities are carried out efficiently and in compliance with applicable regulations and guidelines.
• Identified areas of improvement within existing operations through root cause analysis and benchmarking analysis.
• Overseeing the implementation of reporting rules in the ARISg PV database.
• Developed long-term relationships with key stakeholders to proactively identify and discuss opportunities for process improvements to increase the effectiveness and efficiency of the WWPS organization.
• Developing a PV Control document to standardize processes in alignment with local regulatory requirements.
• Participated in recruitment initiatives by interviewing potential candidates and selecting suitable hires.
• Training of new employee in distributor, Business partners on PV SOPs.
• Ensure adequate and timely escalation of incidents, issues, and/or potential deviations. Lead formal investigations of issues as they arise, ensuring timely escalation to line management if critical observations or critical issues are not resolved.
• Provide guidance during the development and execution of corrective and preventive actions (CAPA) relating the submission issues. Coordinate and review CAPAs to ensure adequate root cause analysis and systemic solutions.
• Involved in audit and inspection readiness and mitigation.
• Preparation and maintenance of ICSR and SAR's Pharmacovigilance System Master file (PSMF) in One safe.
• Coordinated with the IT department to implement new technologies and systems enhancements in the compliance database.
• Reviewing Quality System Manual and IPVCD documents as needed.

Manager, Case Management ICSR Processing supports the Worldwide Patient Safety vision through understanding the impact and implication of daily work deliverables, policies, and procedures on all stakeholders of single case safety reporting. This commitment drives dedication to quality and adherence to global, single-case regulatory reporting requirements. This role provides oversight of the management and execution of Safety Data Processing from global sources through a Business Partner model, working with multiple global stakeholders across WWPS and external functions. The role requires oversight of productivity, quality, and process optimization and ensures business continuity for compliance-critical safety data processing to support regulatory obligations.

Position responsibilities:

• Performed ICSR case processing oversight activities within a matrix environment to achieve oversight and execution of global single case safety processing and reporting requirements in accordance with global regulations, operating within a business partner optimization model.
• Managed and executed day-to-day operational aspects of ICSR Case Processing in collaboration with business partners and stakeholder functions to ensure continuous compliance and high quality of ICSR process.
• Managed day-to-day oversight and execution of project-related work as required, supporting ICSR process optimization, including implementation of regulatory requirements and standards.
• Collaborated and supported effectively during database implementation with IT business partners and business process owners to troubleshoot issues during Hyper-care.
• Was responsible for many case intake projects, including planning, organizing, and managing activities. Some examples include managing duplicate processing, clean-up of intake failures, and other data clean-up projects.
• Responsibilities related to handling of ICSR Duplicates/Case Deletion.
• Served as an SME for handling duplicates and confirming duplicate cases with Health Authorities such as EMEA, HA Canada, Business Partners, Local Markets, and other sources.
• Serving as a trainer, mentor, and guide for colleagues, vendor teams handling invalid cases, case deletion, and medical information queries.
• Reviewing quarterly metrics on deletion cases and providing root cause assessment and implementation of CAPAs.
• Involved as POC in SUSAR Best Practice Forum, streamlining the process between SUSAR and Intake teams.
• Serving as the Innovation SME for intake to find potential opportunities for innovation and optimization of existing processes.
• Intake SME for industry standard practices (ISP) working group meeting
• Involved with safety database and quality database (Veeva Infinity) integration workshop to identify all major root cause contributing to large volume of Non-PQC/Duplicate received from solstice integration.
• Expertise in utilization of Document Image Management Systems (DIMS) and query handling within DIMS.
• Addressing critical case creation questions related to incoming ICSR reports to Central Safety Mailbox and mailbox management.
• Assisting Triage Associates in questions related to identification of SUSARs, tracking files, and establishing processes required for adequate processing and archival of incoming reports.
• Ensure the Central Safety Inbox is managed, and all emails are addressed on time.
• Responsible for training new team members and vendor teams on processes and activities related to case creation, triage, and inbox management.
• Liaised with local PV Safety teams to resolve key issues related to download of Canadian Health Authority ICSR reports.

Senior Drug Safety Expert responsibilities in Accenture Services Pvt (Client: Teva Pharmaceuticals) Period: Jul-2015 till Jan-2017

Responsibilities include assigning cases to the team by periodic monitoring of the ArisG work lists, strict adherence to internal and external timelines, and effective team management.

· Triage of incoming reports to determine seriousness for prioritization of daily workflow as well as for completeness and validity.

• Responsible for initial checks and searching the database to prevent duplicate entries.
• Ensure accurate and consistent coding of medical history, drugs, and adverse event terms. Assess adverse event reports for seriousness, causality, and expectedness, as per applicable labeling, consulting the Medical Safety Expert whenever needed.
• Evaluation and QC of Serious Adverse Events / Post Marketing Adverse Events to ensure accurate and consistent data entry and processing from source documents, with emphasis on timelines and quality.
• Perform Peer QC check (quality control) for serious and Fatal ICSR's.
• Mentor and train new hires or other associates on ICSR processing.
• Operations management including workflow distribution and tracking of case to ensure compliance reporting timelines to PVA partners and Health Authorities.
• Quality Review/Peer Review ICSRs, provide root cause assessment for errors observed and ensure Correction and Preventive Actions (CAPAs) are executed.

Drug Safety Reviewer Responsibilities in Accenture Services (Client: Bristol Myers Squibb) Period: Feb-2012 till Jan-2014:

• Responsible for processing all types of cases from clinical trials, spontaneous, and literature origin.
• Coding of Products using WHO dictionary, and Coding of adverse events using MedDRA.
• Assessing seriousness criteria of events using EMA's important medical events list.
• Ascertaining events of special interest using company sentinel event list, product summary.
• Preparation of descriptive ICSR narratives with causal assessment and evaluation comments.
• Identification of SUSARs and Comparator SUSARs.
• Assessment of labeling using reference safety information like CCDS, SMPC, USPI, and IBs.
• Handling all follow-up activities involved in the creation of auto-letters in safety databases and monitoring study queries in clinical databases.
• Collaborates with Medical Review Safety Physicians and Safety and ESR Scientists across therapeutic areas on case-related issues, while seeking guidance from AE Processing managers.
• Experience in submission of ICSRs, prepared cases for submission to business partners, Health Authorities such as EMA, FDA, and MHRA.
• Ensure compliance with global and local procedural documents and local implementation of Patient Safety objectives, policies, processes, and procedures.

Case Processing Associate Responsibilities in Accenture Services (Client: Bristol Myers Squibb) Period: Feb-2010 till Jan-2012:

• Case processing of ICSRs completed basic elements of the case. Check for case validity.
• Responsible for duplicate checks through Safety Database search interface.
• Completion of General screen, Reporter details, and Patient demographics pertaining to ICSRs.
• Coding of Study Medications, Suspects, and Concomitant medications using product dictionary.
• Completion of product attributes, including dosage regimen and frequency, and action taken with the product.
• Pick appropriate Adverse Events/SAEs and code using MedDRA, and provide an initial assessment of seriousness criteria.
• Enter appropriate laboratory data relevant to adverse events and process information from medical records.
• Responsible for handling data entry of Special Scenarios, such as legal cases, pregnancy cases, off-label use, and medication errors.
• Perform reconciliations of ICSRs based on reports received from the Oracle Clinical database and Safety Database.
• Peer review, QC check to ensure quality and accuracy.
• Update operational dashboards, 3x3 charts, and operations tracker on a daily basis.