VENKATA KISHORE KUMAR DARISI

Experience

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  Novartis

  Feb 2011 - Mar 2021

  -To update core safety information, supported by expert statements and commented track change versions of the CDS.-Preparation of RMPs and/or Medical Risk Assessments according to legal requirements and internal procedures. Medical Review of RMPs and/or Medical Risk Assessments prepared by colleagues.-Handling of Assessment Reports / Health Authority feedback / questions and preparation of answers to Health Authorities for RMPs and/or Medical Risk Assessments.-Tracks signals in the signal management tracking system, and evaluates line listings and safety information in scientific literature, including reference product information and regulatory authority communication.-Manages 3rd party providers for the production of CDS and related documents.-Plans and initiates CDS updates/periodic reviews with service provider.-Presents safety issues to the Safety Management Board / other internal boards as needed.-Trains and develops / coaches new colleagues (internal and/or external) supporting the CDS team.-Responsible for department output regarding timeliness, volume and high quality of CDSs.-Keeps WIs / SOPs / GOPs for the area of responsibility up to date with internal (e.g., QMs) and external (e.g., GVP modules) requirements, provides input to such procedural documents of other functions, and ensures implementation of such procedural documents in the area of responsibility.-Assist in monitoring the safety profile of products potentially including activities such as literature review, evaluation of individual cases or signal detection Show less Assist in monitoring the safety profile of products potentially including activities such as literature review, evaluation of individual cases or signal detection. Support for signal evaluation and analysis Together with the BSL/PVL, co-author the PSUR including analytical input to PSUR for known and potential risks defined in the RMP.With BSL/PVL, assist in the development, maintenance and implementation of the RMP including the coordination with other line functions for associated activities such as updates, management of large datasets for analysis purposes and the ongoing tracking of commitments and effectiveness measuresAssist in evaluating and writing other safety deliverables including but not limited to clinical overviews, adhoc health authority queries, drug safety product profile (DSPP), drug safety update report (DSUR)Assist in providing safety input to DRA and clinical documents (e.g. core data sheet and investigator brochure)Play an active role in standing and ad hoc Safety Management Team (SMT) and Safety Project Team (SPT) meetingsPlay an active role in Signal detection board and medical safety review board meetings including preparatory activitiesInterface with the clinical team for safety matters including follow-up on events of interest and input into site queries regarding adverse events, updating on PVO requirementsLead the training and mentoring of internal and cross-functional team members Show less Acted as SME (subject matter expert) in CTSO (clinical trial safety operations) team for NSO (neuroscience and ophthalmolgy) portfolio.Handling of NSO clinical trial ICSR'sPreparation of Guidance documents related to clinical trial ICSR processing to attain quality of ICSR's.Management of RSI for Novartis products based on DSUR periodHandling of data reconcilion activities between clinical database and safety database.Providing onboarding training to new hires in Pharmacovigilance team.Training of new hires in the team.Involved in Health authority and license partner inspections.Supporting for internal audits.Support in creation of medical device configurations and ICSR processing rules.Acted as SPOC for health authority queries and other queries related to clinical study protocols and ICSR realted issues.Performed Quality checks of ICSR'sReview of literature articlesSupport in Quality improvement plans and quality checks to the teamReview of clinical study related documentsReviewing and performing study configurations and preparation of Product and study guidance documents.Handling the queries from Vendors.Monitoring and involved in maintenance of compliance with regulatory authorities and license partner or collaborative pharmaceutical companies.Involved in providing the route cause analysis for the critical and potentially late reports to Health Authorities and providing feedback and suggesting corrective actions to the associates to avoid late reporting and to minimize error rate.VAP (Validation and planning) module reviews of new studies. Show less ICSR Processing.Manage and lead the therapeutic area (TA) specific processing team (Neurosciences and Ophthalmology) and ensure that all tasks are performed according to business rules, guidelines and standard operating procedures. Acted as TA coordinator to manage NSO group and train the team with the updated conventions to achieve better quality of ICSR (individual case safety report) and to familiarize with the new processes. Set up the training plans for new hires and ensure that training and mentoring is provided to TA team as appropriate. Support the training of other departments in clinical safety related procedures/regulatory obligations.Interact and assist with the Medical Safety Physicians on project activities in specific therapeutic areas, compatibly with the timely processing/production of individual case reports and regulatory periodic reports. Preparation and updating of PGD (product guidance document) for NSO related products as per the guidelines and RMP (risk management plan) requirements. Assistance in preparation of Aggregate safety reports. Show less

  • Safety Labeling Manager

    Aug 2018 - Mar 2021

  • Medical Safety Expert (Previously known as Pharmacovigilance Expert)

    Aug 2017 - Aug 2018

  • Pharmacovigilance Scientist

    Sept 2015 - Aug 2017

  • Senior Safety Processing Expert

    Apr 2013 - Sept 2015

  • Safety Processing Expert

    Feb 2011 - Apr 2013
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  Aspen Pharma Group

  Mar 2021 - Jun 2023

  Lead- Medical Writing, SERM, Signal Management and Safety Labeling

  -Manage the medical writing team and act as a central point of contact for safety variations, including liaising with Regulatory Affairs to plan and coordinate safety variation submissions. -Investigating any non-compliance with safety variation submission deadlines and lead the ongoing development of the processes needed to ensure that safety variation regulatory requirements are met.-Develop a framework for setting internal and external deliverables against each medical writing project, to include project goals and objectives and measurement criteria, and business outcomes for each project goal-Conduct leadership, training, and support of junior medical writing staff.-Establish and monitor Key Performance Indicators (KPIs) for each staff member and ensure that annualreviews take place according to company policies-Project management of contractual and financial aspects of all medical writing projects and the effective utilization of resources to keep processes cost-effective. -Identification of project challenges to departmental line management and the financial impact thereof. Show less

• 

  GSK

  Jun 2023 - now

  SERM Associate Scientific Director

  • Act as a Safety Lead and develop safety strategy for assigned products and maintain oversight of the execution of the safety strategy.• Provides high-level scientific expertise in the safety evaluation and risk management of key GSK assets or other highly complex products in clinical development and/or the post-marketing setting.• Lead and drive safety evaluation activities for complex products, ensure that appropriate safety objectives and risk minimization strategies are included in clinical development and/or the post-marketing setting, and show confidence, credibility, and influence at all levels of the organization.• Supports effective decision-making for ongoing safety activities.• Drive and ensure that adverse events and other safety information is efficiently evaluated and that safety reports are completed accurately and in a timely manner to meet global compliance and regulatory requirements, and drive implementation of risk management initiatives.• Presents the safety strategy for products at key internal GSK meetings and represents GSK externally at meetings with regulatory authorities, external consultants, and other companies such as licensing partners.• Provide strategic inputs and data for safety sections for maintenance of labeling for assigned products and support licensing activities. Presents labeling recommendations for complex issues to the GSK Global Labelling Committee or Global Safety Board.• Acts as a Subject Matter Expert in the team on scientific aspects and processes related to SERM activities.• Provides functional training, mentoring, and coaching for staff in the team, as necessary.• Lead and represent SERM and support during regulatory authority inspections, internal audits, and process improvement activities.• Assist SERM Line Managers/Project Managers in the management of safety projects as a functional expert and provide recommendations for continuous improvement. Show less