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Suman

SUMAN CHANDRA MAARISETTY

B Pharm, MSc

Director - Operations

Prior to Vigi Medsafe

  • Experience – MHRA (UK), Eli Lilly (UK), Novartis (UK & India)
  • Expertise on databases – Sentinel, Argus, AERS
  • Extensive working knowledge on Triaging and monitoring dedicated safety mailboxes,
  • Processing the ICSR’s (Clinical trials, Spontaneous Reports, Literature, PMS, pregnancy and device reports) and authoring of aggregate reports
  • Was “Key Opinion Leader” for case processing and non‐case processing activities
  • Was Subject matter expert, for quality sampling, data reconciliation, mentoring and providing training to all the stakeholders

At Vigi Medsafe

  • Key driver for all critical pharmacovigilance activities
  • Point of contact to develop and implement Pharmacovigilance strategies
  • Provides support in Data Entry, Peer Review, Literature screening
  • Human resources development by identifying one’s potential, provide appropriate training and conducting workshops and seminars
  • Human resource management – allocation of the correct workflow for the correct person
  • Tracking tool maintenance for 100% compliance in daily workload management
  • Gap analysis and error trend analysis for developing training to bridge the gap
  • Represents Vigi Medsafe at client meetings to provide responses, status updates of ongoing projects, regulatory changes around the world etc
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