Experience

• 

  Kinapse

  Jul 2014 - Jan 2015

  Pharmacovigilance associate

   Undertook information processing activities with extremely high reliability, high quality and in tight timelines according to standard processes and operating procedures. Manual recoding of terms, EVPRM Creation or any other related activity as per the project requirement. Client xEVMPD, DCT creation and Submission of records EMA xEVMPD, xEVPRM creation as per EMA guidelines

• 

  Quintiles

  Feb 2015 - Jun 2015

  Phamacovigilance coordinator

  Completion of full case information on the database (SCEPTRE), culminating in quality review to ensure accuracy and completeness. Activities include:• Triage of incoming cases to determine seriousness for prioritization of daily work flow• Confirmation of Safety coordinator case registry data• Database searches as necessary• Completion of literature searches as necessary• Completion of remaining case data entry, including narrative or auto-narrative• Completion of risk and quality (label approval, manual coding and quality review steps)• Clarification of unclear or illegible information from the Local Safety Officer or Call Centre and customer communication as per the project requirement• Discuss source documents, coding conventions and ad-hoc queries with Medical Assessment Physician• Completion of protocol request forms as necessary• Preparation of deviation memo as necessary• Request deletions as necessary Show less

• 

  Freyr solutions

  Aug 2015 - now

  • Supporting team as a Regulatory Associate (RLA) in performing Translation QC and English QC of EU (Central and Non-central), LATAM, JAPAC regions as per regional requirements.• Making updates and variation changes to local labels with respect to reference labels (Base Document creation and review).• Handling documentum system for client (EPIC tool).• Preparation and compilation of Delivery Summary reports for the assigned tasks.• Perform peer review activities for Regional Prescribing Information (RPI - including PI & leaflet, & IFUs) as appropriate at submission and prior to artwork creation (i.e. proofreading, formatting, alignment to regional templates, client reference guide).• Preparing label comparison as per the region requirement.• Creation and review of SPL with respect to US labelling.• Perform the activities involved in EU-Linguistic review.• Proof reading the artwork labels.• Perform the PCL activities.• Preparation of Biosimilar Product Labels.• Perform review activities for CCDS including prrof reading, formatting as per client reference guide and templates. Show less  Prepare/amend the Regional Prescribing Information (RPI) for Rest of World Labelling by performing the below activities but not limited to: • RPI base documents for MAA and variations • Red-line and clean versions of RPI revisions • Comparison tables where appropriate in MS WORD • Approval workflows in document management system Perform peer review activities for Regional Prescribing Information (RPI - including PI & leaflet, & IFUs) as appropriate at submission and prior to artwork creation to include but not limited to: • Proofreading, formatting, alignment to regional templates, client reference guide. • QC of ROW translations of labelling documents - Prescribing and Patient Information to be in line with Translation QC process Conduct training programs and support fresher’s to get on board.  Perform following activities with respect to EU labelling, Linguistic review: • QC prior to review, processing comments, prep of final translation submission (redline, clean, book mark PDFs) • Adding dates & PV contact details prior to artwork creation. Show less

  • Manager - Medicinal Products Labeling

    Apr 2023 - now

  • Deputy Manager - Medicinal Products Labeling Services

    Apr 2022 - Mar 2023

  • Assistant Manager - Global Labeling Management

    Apr 2020 - Mar 2022

  • Team Lead - Global Labeling Management

    Apr 2019 - Mar 2020

  • Senior Associate - Global Labelling Management

    Apr 2018 - Mar 2019

  • Associate - Regulatory Operations

    Aug 2015 - Mar 2018