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PROJECTS

Top 5 Indian MNC

  • ICSR Processing using client’s Argus database v 8.x.x
  • Handling case volume of approximately 40000 to 50000 cases annually in all work flows (Triage, book‐in, data entry, peer review, medical Review, follow‐up and closure)
  • Signal detection activity on invalid literature
  • Literature review of citations and full‐text articles
  • SDEA preparation and review
  • Multiple ad‐hoc projects – all delivered
  • Database migration activity to Argus– completed

Top 50 Indian MNC:

  • Case processing of live expeditable and periodic cases (including medical review) on client’s Argus v 8.x.x database – approximately 40000/year
  • Literature Review for molecules on two major databases
  • Signal Management activity for molecules including labeling updates
  • Authoring of package inserts
  • Authoring of Aggregate Reports for regional submission
  • Risk Management Plans for licensed products for international submission

Top 50 Indian MNC:

  • Signal Management activity from literature screening and review (including bio-similars)
  • Literature screening and review for authoring of Aggregate Reports (including bio-similars)
  • Authoring of safety documents –Risk Management Plans and Aggregate Reports
  • Individual Case Safety Reports processing from literature sources using Argus database

Indian company (API manufacturer now into Formulations)

  • Complete PV system set up including writing Standard Operating Procedures
  • Case processing activity using Safety Easy PV (AB Cube’s) supplied by Vigi Medsafe
  • Aggregate reports and Risk Management Plans authoring
  • Signal management activity
  • Call centre set up for US region and the UK

Indian company (Acquired by EU Pharmaceutical company)

  • Complete PV system set up including writing Standard Operating Procedures
  • Case processing activity using Safety Easy PV (AB Cube’s) supplied by Vigi Medsafe
  • Aggregate reports and Risk Management Plans authoring
  • Signal management activity
  • Authoring of reference safety information for India and beyond

Indian company (Globally renowned generic manufacturer)

  • Risk Management Plans
  • Signal detection activity
  • Ad-hoc training on GVP modules for their in-house employees

Ukranian MNC:

  • Set up of the PV system in collaboration with network partner in Germany
  • Literature screening for ICSRs for seven generic products on PubMed
  • End to end case processing on Argus database supplied by Vigi Medsafe
  • Quarterly Signal Detection activity and Safety Review Meetings for seven products
  • Risk Management Planning activities in collaboration with the EUQPPV

Indian company (now acquired by Top 5 generic players in the world)

  • Processed 3500 Individual Case Safety Reports in 2 months using client’s AERS Database
  • Conducted Signal Management activity for 201 molecules including labeling updates

German MAH

  • Risk Management Plan for a hybrid generic for BfARM, Germany submission

German MAH

  • Aggregate Reports for Russia submission.
  • Aggregate Reports for BfARM,Germany submission

German MAH

  • Risk Management Plan for BfARM,Germany submission

Switzerland MAH

  • Risk Management Plan for Switzerland submission

Israel MAH

  • Risk Management Plan for EU submission
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