Tabhitha Kativarapu

· Assign and allocate resources for new projects, assessing staffing needs for current and future endeavors.

· Manage project budgets and hours, delegating work to staff as per allocated resources.

· Review timesheets and T.I.M.E. utilization reports, contributing to monthly reports for performance analysis.

· Collaborate with the Senior Director of Safety Operations in recruitment and termination processes.

· Coordinate mentoring and training programs for new staff, ensuring continuous skill development within the department and interdepartmental collaboration.

· Conduct annual staff appraisals, providing recommendations for promotions, career advancement, and addressing employee issues impacting project performance and team dynamics.

· Prepare for and respond to internal and external audits and inspections.

· Ensure compliance with Service Level Agreements (SLAs) and achieve defined Key Performance Indicators (KPIs) focusing on quality, compliance, and training.

· Provide functional expertise and oversee processes, addressing queries from the PV Operations staff.

· Participate in client meetings and internal team discussions as needed.

· Lead a team of 10 professionals.

· Organize mentoring and training, working in collaboration with local quality and training staff.

· Maintain awareness of team performance issues and keep line manager informed.

· Ensure effective communication of important decisions and policies to the team, including those discussed with senior management or clients.

· Maintain awareness of regulatory changes and compliance with client and company Standard Operating Procedures (SOPs).

· Inculcate leadership and professional skills within the team.

· Led and managed projects with a primary focus on Safety and Pharmacovigilance services.

· Assigned project tasks and reviewed workloads for direct reports.

· Developed, reviewed, and ensured the execution of Safety Management Plans and Safety Reporting Plans.

· Evaluated processes for efficiency and recommended improvements, actively participating in process development and departmental enhancements.

· Represented Safety and Pharmacovigilance at project and client meetings.

· Reviewed, advised, and approved Safety sections of project proposals to accurately reflect the scope of work.

· Ensured compliance with SOPs, WIs, global regulations, GCPs, ICH guidelines, and GVP modules.

· Identified, prepared, and delivered necessary training to the Safety team and mentored team members.

· Participated in audits/inspections, maintained inspection readiness, and contributed to quality investigations and corrective actions.

· Maintained awareness of local drug safety reporting requirements and handled electronic reporting for sponsors.

· Led the setup and deployment of global reporting to regulatory authorities, ECs, and investigator sites.

· Worked with the Global PV Information Office to organize global PV requirements.

· Managed the submission of periodic safety reports and safety reports to investigators via ISIS.

· Oversaw measurement of investigative site performance in conducting required tasks in ISIS.

· Tracked and filed submission cases, including un-blinding SUSARs when necessary.

· Liaised with internal and external safety processing teams to facilitate expedited and periodic report submissions.

· Identified and documented non-efficient processing methods and highlighted process improvements.

· Conducted User Acceptance Testing (UAT) on new databases and assisted in configuring databases with project-specific information.

· Mentored newly joined team members.

· Led and managed small-sized projects with a team of six members.

· Documented quality issues, implemented corrective and preventive actions as needed.

· Performed all tasks in accordance with GCP, GVP modules, SOPs, and project-specific requirements.

· Created and reviewed SOPs and WIs as necessary.

· Demonstrated the ability to manage multiple projects.

· Assisted in the investigation, processing, and maintenance of deviations and related CAPAs.

· Implemented PV Audit and Inspection Readiness processes.

· Recognized with badges of Empowerment and Accountability, Collaboration, and Expertise in 2021.

• Developed and implemented Expedited Reporting Procedures.
• Maintained compliance with drug safety reporting requirements.
• Registered and liaised with relevant authorities for electronic reporting on behalf of sponsors.
• Orchestrated the setup and deployment of worldwide reporting to regulatory authorities, CECs, local ECs, and investigator sites.
• Managed the submission of periodic safety reports (e.g., DSUR, ASR).
• Submitted safety reports to investigators through the International Safety Information System (ISIS).
• Tracked and filed submission cases as required.
• Unblinded SUSARs as needed.
• Collected and reviewed metrics to measure reporting compliance.
• Collaborated with the Global PV Information Office to collect and organize global PV requirements.
• Ensured quality control of case reports, line listings, and tabulations.
• Distributed data to Regulatory Authorities, Ethics Committees, investigator sites, and marketing authorization holders based on clinical trial approvals.
• Demonstrated expertise in various formats of Individual Case Safety Report (ICSR) reporting to Regulatory authorities, including XML format for EVWEB reporting and transmission, portal submissions, courier services, and manual email submissions of CIOMS and MEDWATCH.
• Managed XEVMPD Submission and product registration.
• Acted as Responsible Person (RP) for the sponsor.
• Proficiently navigated local drug safety reporting requirements.
• Created, maintained, and oversaw study-specific submission templates and trackers.
• Measured investigative site performance in conducting required tasks within ISIS.
• Recognized with badges of Teamwork, Ownership, I Delight the Customer, and I Own the Problem and Solution in 2020.

· Developed project-specific safety procedures, workflows, and templates.

· Led project-specific safety database setup, data entry guideline development, and user acceptance testing.

· Organized and coordinated study-specific workflows for processing and reporting Serious Adverse Events (SAEs).

· Coordinated case reconciliation activities with Data Management personnel.

· Generated line listings and tabulations for safety reports, including periodic safety reports and ad hoc safety reports.

· Ensured quality control of case reports, line listings, and tabulations.

· Provided drug safety and project-specific training.

· Prepared for, participated in, and followed up on audits and inspections.

· Delegated work as appropriate to Drug Safety Assistants or Drug Safety Associates.

· Processed Individual Case Safety Reports (ICSRs) from various sources.

· Electronically documented and ensured the quality control of drug safety information.

· Created and maintained project-specific working files, case report files, and project central files.

· Performed literature searches and reviews.

· Participated in client and investigator meetings as required.

· Attended internal, drug safety, and project-specific training sessions.

· Recognized with badges of Client Services and Quality and I Say What I Think in 2017.

· Processed Individual Case Safety Reports (ICSRs) from various sources.

· Electronically documented and ensured the quality control of drug safety information.

· Created and maintained project-specific working files, case report files, and project central files.

· Performed literature searches and reviews.

· Delegated work as appropriate to Drug Safety Assistants.

· Developed project-specific safety procedures, workflows, and templates.

· Led project-specific safety database setup, data entry guideline development, and user acceptance testing.

· Triage incoming reports for completeness, legibility, and validity.

· Data entry of case reports into the safety database and tracking system for seriousness, causality, and expectedness, and the resulting reporting requirement.

· Requested follow-up and performed query management.

· Coded data in the safety database.

· Wrote case narratives.

· Coordinated case reconciliation activities with Data Management personnel.

· Generated line listings and tabulations for safety reports, including periodic safety reports and ad hoc safety reports.

· Assisted with Senior Drug Safety Specialist and Medical Operations Leader (MOL) activities as required.

· Supported Medical Directors/Safety Physicians, as needed, in medical monitoring activities.

· Participated in client and investigator meetings as required.

· Attended internal, drug safety, and project-specific training sessions.

· Prepared for participation in and followed up on audits and inspections.

· Planned and scheduled activities, assigning tasks to the team and providing guidance in processing assigned work.

· Interacted with clients and team leads to ensure project compliance with quality standards and deadlines.

· Performed Quality Review and Data Entry, along with other relevant activities.

· Managed case processing, including collecting, triaging, analyzing, and reporting safety information for marketed products.

· Assessed case reports for seriousness, causality, and expectedness, ensuring compliance with reporting requirements.

· Responsible for data entry of individual case safety reports into the safety database.

· Conducted full data entry, including medical coding and safety narrative.

· Coded medical history, events, drugs/procedures/indications, and laboratory tests according to the appropriate dictionary (e.g., MedDRA, Company Product Dictionary, WHO-DD).

· Wrote medically relevant safety narratives for cases and verified the completeness and accuracy of entered data.

· Followed up on the reconciliation of discrepancies.

· Reviewed and evaluated adverse event case information to determine necessary actions based on internal policies and procedures.

· Ensured completeness and accuracy of data entered in the safety database with reference to source documents, SOPs, work instructions, and client guidelines.

· Conducted reviews of the selected coding for compliance with appropriate dictionaries.

· Provided training and mentoring to new hires and trained data entry teams to maintain the highest quality.

· Undertook client and query communications, prepared Minutes of Meetings (MOMs), and prepared project status reports.

· Managed case processing, including collecting, triaging, analyzing, and reporting safety information for marketed products.

· Assessed case reports for seriousness, causality, and expectedness, ensuring compliance with reporting requirements.

· Responsible for data entry of individual case safety reports into the safety database.

· Conducted full data entry, including medical coding and safety narrative.

· Coded medical history, events, drugs/procedures/indications, and laboratory tests according to the appropriate dictionary (e.g., MedDRA, Company Product Dictionary, WHO-DD).

· Wrote medically relevant safety narratives for cases and verified the completeness and accuracy of entered data.

· Followed up on the reconciliation of discrepancies.

· Reviewed and evaluated adverse event case information to determine necessary actions based on internal policies and procedures.

· Ensured completeness and accuracy of data entered in the safety database with reference to source documents, SOPs, work instructions, and client guidelines.

· Conducted reviews of the selected coding for compliance with appropriate dictionaries.

· Provided training and mentoring to new hires and trained data entry teams to maintain the highest quality.

· Undertook client and query communications, prepared Minutes of Meetings (MOMs), and prepared project status reports.