Venkatesh Kalva

Pharmacovigilance Management:

• Currently managing service provider for US based Pharmaceuticals client which operates on ICSR cases processing team and including vaccines.

• Monitoring inflow versus outflow and notify variance on monthly basis to Manager. In addition planning and handling of spikes and volume fluctuations with available resources within team.

• Meeting productivity and Turnaround time as per SLA requirements.

• Identify need for cross workflow steam support and utilize resources within different streams based on requirement.
• Highlight issue areas within team; propose solutions in collaboration with manager and follow-up till completion.

• Ensuring 100% compliance with time coding for all employees. Ensuring weekly and monthly monitoring of time coding.

Quality and Compliance Management:

• Assign project work and reviews workload for direct reports. Provides oversight and guidance on organizational goals and company

• Maintaining Random Check quality/LP partner timelines/Regulatory compliance as per SLA.

• Maintaining expected Productivity and quality as per project KPIs and SLAs, and as per internal departmental expectations.

• Publishing score card on monthly basis (Quality, productivity and other performance dashboard).

• Identifying potential risks and address in collaboration with customer/internal stakeholders.

• Proactive communication with customer on updates and implementation of customer feedback.

• Maintaining team level issue log.

• Ensuring 100 % compliance to CV/JDs/ Training (internal and external).Evaluates processes for potential improvement in efficiency and effectiveness and recommends changes

• Single point of contact for Internal and External Audits preparation and support during Audit.
Strategic Initiatives:

• Identifying areas of opportunities for automation and sharing ideas which have a positive impact on customer satisfaction, productivity, quality, compliance effort per case etc.

• Maintaining internal timelines to close CAPA and ensuring 100% CAPA compliance for process directly impacting overall operations.

• Participates in process development and improvement of departmental functions.
People Management:

• Gained strong experience in handling more than 25 direct reports.
• Line management responsibilities including transfers, hiring, utilization, terminations, training, professional development, performance appraisals, job description preparation, time sheet approval, and employee counseling.

• Advises staff on administrative policies and procedures, technical problems, and prioritization.
• Ensuring employee engagement activities are conducted on weekly basis.
• Monthly and Quarterly recognition of team members on timely basis.

• Planning leaves ahead and with minimal unplanned leaves.

Pharmacovigilance Management:

• Working with service provider for Swiss based Pharmaceuticals client which operates on ICSR cases processing team for multiple therapeutic areas.
• Responsible for day-to-day work, process flows and constantly endeavoring to be able to lead team from front.
• Assessing training needs of PV Staff, Study Management and ensure team on continues training requirement and various employee engagement activities.
• Monitoring of timely completion of safety cases within quality standards. Ensure that SLA and quality is maintained as per customer expectations.
• Tracking of cases along with case distribution and tracking of follow ups on daily basis for project. Timely reporting of Metrics and updating related quality tools/ trackers of operational deliverable.
• Ensure proper tracking of communication with client as and when required.

Quality and Compliance Management:

• Assign project work and reviews workload for direct reports. Provides oversight and guidance on organizational goals and company objectives.
• Evaluates processes for potential improvement in efficiency and effectiveness and recommends changes. Participates in process development and improvement of departmental functions
• Compliance Management in which track ICSR submission to RA as per timeline and do RCA and CAPA for late Submission.
• Independently manage improvement projects in various functions within projects.
• Single point of contact for Internal and External Audits preparation and support during Audit.
• Ensure adherence to internal and client procedures for self and team. Ensuring training compliance and proper documentation is maintained in line for self and team.

People Management:

• Gained strong experience in handling more than 20 direct reports.
• Line management responsibilities including transfers, hiring, utilization, training, professional development, performance appraisals, job description preparation, time sheet approval, and employee counseling.
• Advises staff on administrative policies and procedures, technical problems, and prioritization.
• Directs organization of work within team including duty roasters and vacations, etc.
• Responsible for motivation level and retention of manpower.

Pharmacovigilance Management:

• Working with service provider for US based Pharmaceuticals client and supported ICSR cases processing team and Literature screening for multiple therapeutic areas.
• Quality Review, assessing training needs of PV Staff, Study Management.

Quality and Compliance Management:

• Assigns project work and reviews workload for all direct reports. Provides oversight and guidance on organizational goals and company objectives.
• Evaluates processes for potential improvement in efficiency and effectiveness and recommends changes. Participates in process development and improvement of departmental functions.
• Compliance Management in which track ICSR submission to RA as per timeline and do RCA and CAPA for late submission.
• Single point of contact for all process Improvement activities.
• Independently manage improvement in various functions within projects
• Single point of contact for Internal and External Audits preparation and support during Audit.

People Management:

• Gained strong experience in handling more than 30 direct reports.
• Line management responsibilities including utilization, training, professional development, performance appraisals, job description preparation, time sheet approval, and employee counseling. Advises staff on administrative policies and procedures, technical problems, and prioritization.

Metrics Management:

• Integral role in absence management and workflow management.
• Ensure entire team is reaching their individual targets on daily basis with agreed quality and supporting team when there is high influx of volumes.

• In-charge of and coordinates all case management activities ICSR to be carried out by team and manage current incoming cases to meet timelines [compliance monitoring].
• Receive information on adverse events, perform initial checks, search database to prevent duplicate entries, create case file and initialize received drug safety reports in safety database (ARISg and ARGUS).
• Very strong background experience in ARISg and Argus Safety Database .Experience in handling of spontaneous cases, literature cases and solicited cases.
• Ensure scientific rigor through accurate, complete, and consistent data entry of adverse event reports from source documents with emphasis on timeliness and quality.
• Experience in MedDRA coding, along with handling and using of MedDRA browser and WHODD browser to code medical history, laboratory investigations and adverse event terms. Prepare narratives summarizing essential details of case.
• Ensure timely submission of reports in accordance with applicable regulations.
• Manage case-related information including interpretation of medical conditions, lab results, and procedures and perform self QC of Individual Case Safety Reports (ICSR) before submission.
• Attending weekly teleconference with clients and preparing minutes of meeting.
• Prepared plan for refresher training, user friendly documents for case processing conventions, slide decks for training etc.

• Hands served actively as ICSR case processor and Literature review specialist for European client on multiple therapeutic areas.
• Completion of full case information on database, culminating in Quality Review to ensure accuracy and completeness.
• Activities include, triage of incoming cases to determine seriousness for prioritization of daily workflow, confirmation of Safety Coordinator case registry data, database searches as necessary, Completion of remaining case data entry, including narrative or auto-narrative, completion of quality assessment.
• Clarification of unclear or illegible information from Local Safety Officer or Call Centre, discuss source documents and coding conventions.
• Ad-hoc queries with Medical Assessment Physician, preparation of deviation memos necessary. Review and evaluate AE report information, performs Quality Review step as per applicable SOP(s).
• Expertise on internationally recognized literature databases i.e Embase, Ovid Medline, Pub Med and Reactions weekly as per regulatory requirements.
• Development and optimization of search strings for extracting relevant articles from literature sources
• Thorough review of literature articles for ICSRs and STUDY reports based on valid case criteria and timely reporting of valid articles.
• Maintenance of Literature database for all hits and valid hits
• Prioritizing articles based on seriousness and identifying any products which requires any exchange with partners
• Ordering and tracking of Full publications from E-library.