Open to opportunities

Parmita Phaugat

@parmitaphaugat

Message

I build compliant regulatory submissions and drug-safety programs across global health authorities.

Canada

Message

What I'm looking for

I'm looking to apply my regulatory submissions, pharmacovigilance, medical writing, and cross-functional coordination experience in a role supporting compliant global drug or medical-device development.

At Genvion Corporation, I prepared and technically validated eCTD IND, NDA, ANDA, and MAA submissions for EU and Australia, using Lorenz tools and dispatching through FDA, EMA, and MHRA gateways. I also supported health-authority responses, briefing packages, GMP documentation review, and QMS readiness.

Previously, I led regulatory affairs and pharmacovigilance training at ACPL Group and reviewed drug-safety cases at Clini Resource and Parexel. My PhD research background includes 20+ peer-reviewed publications and two drug-delivery patents, alongside hands-on work in aggregate safety reports, literature surveillance, signal detection, CER/CEP writing, MedDRA coding, and Argus Safety.

Experience

Work history, roles, and key accomplishments

Quality & Regulatory Affairs Specialist

Genvion Corporation

Jan 2024 - Dec 2025 (1 year 11 months)

Prepared and compiled eCTD regulatory submissions including IND, NDA, ANDA, and MAA dossiers across EU and Australia. Performed technical validation and dispatch via FDA ESG, EMA Gateway, and MHRA portal.

CTD IND NDA ANDA MAA LORENZ EValidator FDA ESG EMA Regulatory Submissions QMS GMP CMC Labeling CAPA Change Control Audit Readiness

Training Manager – Regulatory Affairs & Pharmacovigilance

ACPL Group

Jan 2022 - Dec 2023 (1 year 11 months)

Compiled eCTD submissions for CDSCO and served as SME for pharmacovigilance, designing training on ICSR processing, SAE management, MedDRA coding, and aggregate reporting. Developed SOP-based training materials aligned with FDA, EMA, and ICH-GVP.

Pharmacovigilance SAE Management MedDRA Training SOP流程设计 FDA EMA

Senior Pharmacovigilance Scientist

Clini Resource

Jan 2022 - Dec 2022 (11 months)

Performed medical and quality review of ICSRs and SAEs, identifying quality gaps. Contributed to PSUR/PBRER/DSUR preparation and wrote Clinical Evaluation Reports/Plans. Conducted high-volume literature surveillance and signal detection.

Pharmacovigilance PSURs PBRERs DSURs CEP Literature Surveillance Signal Detection PubMed MedDRA WHODrug

Drug Safety Associate

Parexel International

Jan 2020 - Dec 2021 (1 year 11 months)

Processed and reviewed ICSRs from clinical trials and post-marketing sources. Performed case intake, MedDRA coding, narrative writing, and quality review using Argus Safety Database, ensuring compliance with ICH E2B, FDA, and EU-GVP.

Pharmacovigilance MedDRA FDA Case Processing Narrative Writing Quality Review