Yasaswi V

About Yasaswi V

Experienced Regulatory Global Labeling Operations Manager with a demonstrated history of…

Experience

1. Labeling Operations Manager- Global Labeling Management

   Pfizer

   Feb 2017 — Present

   Supporting the review and delivery of CDS, USPI, SmPC (for products registered in the EU via the Centralized, Mutual Recognition or Decentralized procedures) and their associated Patient Labeling Documents. • Consolidation of labeling versions. • Consolidating comments from Labeling reviewers and Regulatory Authorities. • Preparing comparison tables for labeling team discussions. • Editing and formatting labeling documents- To ensure the document complies with the appropriate template (e.g, QRD, PLR). • Generate necessary renditions in GDMS (e.g, clean and marked PDF, clean and marked MS Word) and bookmark renditions as appropriate. • Facilitated workflow through corporate document repository, e.g, GDMS. • Utilized PfLEET2 to track labeling projects. • Finalized documents post QC (including update of GDMS document properties such as entry of PfLEET2 number, update of document title, update CDS cover page etc.). • Will manage the document status in GDMS and notify internal stakeholders of the availability of labeling documents. • Order SPL for USPIs, check and upload to GDMS upon receipt, notify internal stakeholders of its availability (e.g, Regulatory, Drug Listing). • As LOM, I am also responsible for updating related labeling documents e.g, for products within a similar class, of different dosage forms, and for generics. • Used to set clear targets for review and approval timelines for labeling documents using effective project management. And I also use to follow up with Labeling Team members to ensure timely review and approval deadlines are met. • Also responsible to update and maintain the CDS logs. • Ensure all actions taken within role follow applicable SOPs and associated documents so that high quality delivery of outputs and compliance is maintained. And also use to ensure appropriate tracking of labeling projects via defined procedures and optimal use of systems.