Shivani Sudhakar

eTMF Specialist | PharmD

Role
Document Management Associate at Novotech
Location
Mangaluru, KA, IN
LinkedIn followers
500 followers

About Shivani Sudhakar

IQVIA leverages my expertise as a Document Specialist to manage Trial Master File (TMF) documents across all levels using VeevaVault Clinical. My work focuses on maintaining compliance with ALCOA++ principles while supporting clinical trial processes with precision and dedication. Graduated from NGSM Institute of Pharmaceutical Sciences with a PharmD, I bring a foundation in pharmacy and hands-on experience as a trainee pharmacist and intern. Motivated to expand into regulatory affairs, clinical data management, and medical writing, I am committed to continuous learning and contributing to impactful projects in the clinical research domain.

Experience

  1. Document Management Associate

    Novotech

    Jun 2025 — Present · Bengaluru, IN

    QC review of TMF documents as per ALCOA++ principles, essential documentation and GDP principles. Ensuring TMF is filed with highest quality and is always Inspection Ready (IR)

Education

  • St. Agnes PU College - India

    PUC, PCMB

    2015 — 2017

  • St. Agnes' Convent Higher Secondary School

    Sslc

    2013 — 2014

  • NGSM Institute of Pharmaceutical Sciences

    Doctor of Pharmacy - PharmD, Pharmacy

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Shivani Sudhakar — Document Management Associate at Novotech in Mangaluru, KA, IN | Unifers