Santhosh YL

Experience

• 

  Adichunchanagiri Institute of Medical Sciences

  Mar 2010 - May 2011

  Clinical Pharmacist and Research Associate

  Co-ordination in conducting many prospective interventional research studies and patient educational programs

• 

  Molecular Connections

  Jun 2011 - Jun 2012

  Scientific Analyst

  Drug Discovery, Drug Label Curatio, Drug Saftey, Bio-Curation

• 

  MMS

  Jun 2012 - now

  # Receive information on adverse events from clinical trial site; perform initial checks, Registry, Triage of incoming cases to determine seriousness/reportability, sending notifications to study team # Allocation of cases to the team based on the timelines and reportability# Completion case processing of serious, non-serious, medication errors /overdose, and legacy cases. (case data entry, labelling according to the IB and SMP, medical coding [using MedDRA and WHO DD and narrative writing/auto narrative) using Oracle Argus Safety# For SUSAR cases, involve in generation of Safety Query forms, Investigators safety letters, FDA submission cover letters, IRB letters, and EC letters.# Quality review of serious, non-serious, medication errors/overdose, and legacy cases.# Generating queries pertinent to the case and follow up with the clinical trial team (CRA, PI, Sub-investigator, and CRC). # Involve in Case filing activities as per the client requirement.# Mentoring/ training of associates on Argus database# Preparing checklists and SOPs for case processing related activities.# SAE reconciliation# Reporting of safety information to Regulatory Authorities EMA, FDA, Other Authorities, and Clinical site investigators# Periodic SUSAR line listings, generation, distribution, and archiving# CSR safety narrative writing:* Worked as a project lead and Co-PL for major clients in CSR narrative writing projects and successfully delivered on time with good quality.* Lead several safety activities on assigned project’s that may include interactions with other cross functional departments such as medical writers, document specialist, and Quality control team* Write CSR narratives using clinical data listings.*Participate in client meetings / project specific updates. Follow up with Clients regarding outstanding queries and reconciliation of discrepancies. Generation and management of query logs, resource tracker, deliverable tracker and comment logs. Show less

  • Manager Drug Safety and PV

    Jan 2024 - now

  • Associate Manager Drug Safety and PV

    Jan 2023 - Dec 2023

  • Senior Team Lead, Drug safety and Pharmacovigilance

    Jan 2021 - Jan 2023

  • Team Lead Pharmacovigilance

    Apr 2019 - Jan 2021

  • Pharmacovigilance professional

    Jun 2012 - Mar 2019