Poonam Malode

Experience

1. Medical Writer

   Lupin Ltd

   Mar 2022 — Present · Pune, IN

   Preparation of Clinical Study Report (full and/or synoptic ICH E3-compliant CSR) within proposed timeline according to the CDISC requirements and/or as per the regulatory requirements. Review of draft and/or final Clinical Study Report obtained from different CRO and provides inputs or comments to the dossier. Preparation of eCTD module inclusive of Module 5, 2.5, Module 2.7, listings of clinical studies (table 5.1), CSBE and other related documentation for obtaining marketing authorization of pharmaceuticals in (EU) European region, USFDA, Canada. Compliance of checking, linking, bookmarking, review of documents, Rendering Multiple Documents to PDF, Creation of external links in eCTD format. Review of Tables, Listing and Figures (TLFs) and Statistical Analysis Plan. Preparation and review of Pharmacokinetic and Statistical Report. Preparation of Clinical Information for Bioanalysis. Preparation and review of Informed Consent Documents (ICD). Handling of regulatory query responses. Preparation and Review of in-house Standard Operating Procedure (SOP). Verifying that data entered on to the Case Report Form (CRF) is consistent with source data/document verification. Review the project specific raw data for accuracy, completeness and internal consistency and compliance to SOP’s, Protocol and CRF’s.

Education

• Pune University

  M.Pharm, Pharmacology

  2007 — 2012

• K.T.H.M College Nashik

  HSC

  2006

• New English School

  SSC

  2004

• NGSPM'S College of pharmacy, Nashik

  B.Pharm

  2006 — 2010

• Sinhgad institute of pharmaceutical sciences, Lonavala

  M.Pharm (Pharmacology), Pharmacy

  2010 — 2012

Skills

• Animal Handling
• Pharmacology
• Clinical Trials
• Research
• Research and Development
• Animal Work
• Ich-Gcp
• Microsoft Word
• Microsoft Excel
• Ms Office
• Clinical Research
• Pharmacovigilance