Murali Krishna

Experience

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  Tata Consultancy Services

  May 2014 - Jan 2016

  Senior Drug Safety Associate

   Responsible for identifying duplicate/invalid ICSRs in ARISg and handling as per relevant SOP Review of latest received date (LRD) of incoming licensee cases with reference to Pharmacovigilance Agreements (PVA) and Safety Data Exchange Agreements (SDEA)  Accountable for performing accurate data capture for Individual Case Safety Reports which can be Spontaneous, Clinical, NIS and NIP cases Responsible for generating and forwarding appropriate queries and requests for clarification and/or follow up information Sending MedDRA 18.0, requests as needed and discussing with operation physician team regarding the amendment/split and raising queries regarding the events Narrative writing as per regulatory format  Accountable for performing the appropriate clinical assessments (including the assessment of seriousness, labeling and company causality for each adverse event) adhering to SOPs/other controlled documents and regulatory requirements  Assuring and maintaining compliance with Regulatory and Local/Global SOP timelines using proactive work flow management  Responsible for developing a collaboration with relevant Drug Safety Personnel for maintaining awareness of critical AEs, knowledge of labeling documents, and other issues for company products Identifying potential SUSAR’s cases and process them on priority Raising queries to Safety Responsible personnel for missing information Adhering to productivity, timeline compliance and quality of cases Managing blinded therapy cases Demonstrated knowledge of safety concepts, global regulatory reporting obligations, relevant PDSO SOPs, Pharmacovigilance Agreements and Safety Data Exchange Agreements Show less

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  IQVIA Asia Pacific

  Jan 2016 - Nov 2020

  Operations Specialist I

  • Responsible for the processing of Individual case safety reports in the Oracle Argus Safety Database.• Processing post-marketing safety data by receiving SAE and adverse event (AE) reports from various sources; identifying SAEs and AEs from literature sources: identifying brand of suspect product following receipt of report. Identifying reporting sources, assessing reportability and expectedness of events.• Participating in continuous improvement of all departmental processes and procedures.• Process clinical trial safety data by triaging initial and update safety data. Reviewing safety data for inconsistencies. Contacting sites with queries as needed, ensuring translation of safety data. Entering applicable safety data into a serious adverse event (SAE) database as needed and writing narratives. Coding terms as appropriate; ensuring initial reports are sent to customers or marketing authorization holders within agreed timelines; updating narratives when updated information is received as appropriate. Show less

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  Syneos Health

  Nov 2020 - now

  I am a Team lead and Quality professional with 8 years of progressive experience with sound knowledge in Quality, compliance, and pharmacovigilance domain. Supported and was part of successful various Pharmacovigilance Audits and supported various internal Inspections. Expertise in deviation, CAPA Management, Internal Audits, Vendor Audits, Facility Audits, Change Management, and Quality Document Management. Expertise in successfully handling all domain-specific aspects of a Pharmacovigilance Process including single case processing, training, and mentoring new members in the case processing team and supporting the team on attaining SLA and individual targets and certified trainer by the vendor.Performs all aspects of the collection, processing, and reporting of individual cases safety reports (ICSR), adhering to all data privacy guidelines, Good Clinical Practices (GCPs), Good Pharmacovigilance Practices (GVP), regulatory guidelines, company, and project/program-specific procedures for clinical trials and/or post-marketing safety programs. Ensures that the project/program activities are completed by agreed timelines, allocated budgets, and required quality standards. Responsible for providing delivery and expertise with minimal oversight. Coordinates workflow to ensure delivery of project/program. Accountable to the Project Lead or Safety Program Delivery Manager at the project/program level and line manager for deliverables. May act as a mentor for less experienced associates. At a project level, may act as Safety Program Delivery Lead for local or regional studies.Currently, I am working on ARGUS (8.1.1) safety database and MedDRA with the latest version 25.0. Show less

  • Sr Safety & PV Specialist

    Apr 2022 - now

  • Safety & PV Specialist II

    Nov 2020 - Mar 2022