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Pranali Darne

@pranalidarne

PV Scientist at IQVIA RDS (India) Private Limited managing Veeva Vault signal lifecycles and audit-ready safety documentation.

India

Message

What I'm looking for

I'm seeking an Aspiring Veeva Vault Administrator / Configuration Specialist role where I can apply my experience with Clinical and RIM Vaults, workflows, metadata, and regulated content.

At IQVIA RDS (India) Private Limited, I support pharmacovigilance signal detection, tracking, and lifecycle activities in Veeva systems. I maintain accurate records and audit-ready documentation and prepare safety evaluation reports and periodic safety documentation.

Previously, as a PV Publishing Specialist at IQVIA RDS (India) Private Limited, I managed Veeva Vault RIM document lifecycles and supported publishing PBRER, DSUR, and PAER reports using CALYX RIM. I also trained users on Veeva Vault eDMS processes and Microsoft Word publishing.

At Tata Consultancy Services, I supported Clinical and RIM Vault document workflows, metadata updates, and submission readiness for clinical and regulatory documents. I also practiced configuring Vault components in training environments.

Earlier, as an Officer – Regulatory Affairs at Kilitch Drugs (India) Ltd., I authored and compiled CMC Module 3 documentation and supported regulatory submissions. I also worked as a Visiting Faculty at AIKTC, School of Pharmacy, delivering lectures on Nutraceuticals.

Experience

Work history, roles, and key accomplishments

Current

PV Scientist

Current

IQVIA RDS (India) Private Limited

Feb 2026 - Present (8 months)

Support pharmacovigilance signal detection and tracking activities through structured data workflows and documentation management within Veeva systems. Manage end-to-end signal lifecycle activities, author safety evaluation reports, and coordinate cross-functional stakeholder meetings.

Veeva Vault Pharmacovigilance Signal Management Document Lifecycle Stakeholder Coordination Regulatory Compliance

PV Publishing Specialist

IQVIA RDS (India) Private Limited

Jan 2024 - Jan 2026 (2 years)

Managed Veeva Vault (RIM) document lifecycle activities including document types, metadata, and workflows to support regulatory submission operations. Supported formatting and publishing using CALYX RIM for safety reports and delivered training on Veeva Vault-based eDMS processes.

Veeva Vault Calyx RIM Document Lifecycle Regulatory Submissions Training Quality Assurance

Process Associate

Tata Consultancy Services

Jan 2021 - Jan 2024 (3 years)

Created placeholders, updated metadata, and implemented document types and security settings in Veeva (Clinical and RIM). Supported workflow initiation, lifecycle management, and ensured publishing and compliance of clinical study reports using TRS publisher, ISI toolbox, and Onstyle.

Veeva Vault Metadata Management Document Lifecycle Workflow Configuration TRS Publisher ISI Toolbox Onstyle LORENZ EValidator Regulatory Submissions

Visiting Faculty

AIKTC, School of Pharmacy

Jul 2020 - Jan 2021 (6 months)

Delivered lectures to B. Pharmacy students on Nutraceuticals, prepared lecture plans and study materials, and mentored students in learning activities and academic evaluations.

Teaching Curriculum Development Mentorship Nutraceuticals

Officer – Regulatory Affairs

Kilitch Drugs (India) Ltd.

Jun 2018 - Oct 2019 (1 year 4 months)

Authored and compiled CMC Module 3 documentation for generic formulations across CTD Modules 1–3. Reviewed source documents for dossier preparation, supported regulatory submissions, and conducted packaging artwork and SmPC reviews.

Regulatory Affairs CMC Documentation ECTD Modules Dossier Preparation Regulatory Submissions SOP Management