Pranali Darne
Regulatory and Safety Documentation Specialist with cross-functional exposure
- Role
- Pv Publishing Specialist at IQVIA
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Pranali Darne
Currently working as a PV Publishing Specialist, responsible for compliance checking PBRERs, PADERs, DSURs and Adhoc reports for EU and US submissions.Worked as a Clinical Publisher (Trainer) where I am actively involved in:Publishing of the Clinical Study Reports with their supporting modular appendices (CTD Module 5.3) and Clinical sections in CTD Module 2 required for IND, NDA, MAA submissions.Generating navigable PDF outputs using TRS Publisher.Performs matching of documents to Report Level Content Plan and Submission Content Plan in Veeva Vault.Management of documents in the client electronic document management system (IMMS, Veeva Vault-Clinical and Regulatory) throughout their lifecycle by uploading, compilation, formatting of word and PDF documents and ensuring submissions readiness of the same. Performing compliance checks of MS-Word using Add-ins and OnStyle v2.6.3 and PDF (Adobe Professional) formatting using ISI Toolbox for completeness and correctness with respect to navigation, Bookmarking and Hyperlinking and other standard attributes as required by regulatory agencies.Documents handled for compliance check: Clinical Study Reports, Protocol and their Amendments, Investigator brochures, briefing documents, CTD modules (Module 5)Communication with clients for managing the deliverables within appropriate timelines with quality.I also hold experience in Processing of ICSRs obtained from Legal and Spontaneous sources using Argus Database and coding of drugs in database using MedDRA and WHO-DD dictionaries. Application and renewals of Manufacturing License, Product Permissions, WHO-GMP certificate, CoPP and other licenses and certificates as per requirement of regulatory agencies for Module 1.Reviewing and compilation of Source documents like PDR, BMR, PV, Stability Studies and Quality Analytical data like Specifications, MOA, as per Pharmacopoeia for Finished product, Packaging material required for Dossier compilation.Dossier preparation as per CTD format and country specific requirements (ROW Market) for generic formulations.Review of Artworks and SmPC as per country requirements.
Experience
Pv Publishing Specialist
Jan 2024 — Present · IN
Education
Anjuman I Islam Kalsekar Technical Campus
Bachelor of Pharmacy (BPharm)
Bharati Vidyapeeths College of Pharmacy Sector-3 CBD Navi Mumbai 400 615
M.Pharmacy, Pharmaceutics
2015 — 2017
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